Blood Fibrinolysis and the Response to Desmopressin in Glomerulonephritis

1994 ◽  
Vol 71 (01) ◽  
pp. 019-025 ◽  
Author(s):  
E J P Brommer ◽  
A W L Van den Wall Bake ◽  
G Dooijewaard ◽  
B J Potter van Loon ◽  
J J Emeis ◽  
...  
Keyword(s):  
Renal Function ◽  
Creatinine Clearance ◽  
Impaired Renal Function ◽  
Acute Stage ◽  
Severe Renal Failure ◽  
Adult Type ◽  
Before And After ◽  
The Mean ◽  
Baseline Levels ◽  
Fibrinolytic Parameters

SummaryFibrinolytic parameters and von Willebrand factor (VWF) antigen were measured in 22 patients with glomerulonephritis (GN) who underwent renal biopsy after desmopressin (DDAVP) infusion. Blood was collected immediately before and after DDAVP infusion, after one week, and 3–6 months later. The main abnormalities on admission were the following: the mean baseline levels of t-PA antigen and VWF were significantly higher in GN patients than in 22 healthy controls; the median t-PA activity and the mean scu-PA level were significantly lower than normal . The t-PA response to DDAVP was impaired in 7 patients (32%), the response of VWF in 9 patients (41%), and the u-PA: Ag response in 11 patients (50%). When the patients were stratified according to creatinine clearance rate, significant differences between the subgroups with severely and moderately impaired renal function were noted: the baseline levels of PAI activity and VWF were higher in patients with severe renal failure and the VWF response to DDAVP was significantly lower. The response of u-PA (not of t-PA or VWF) to DDAVP appeared to correlate with urine flow during the first 24 h, suggesting the dependence of u-PA release on intact nephrons. A series of 18 patients with adult-type polycystic kidney disease (APKD) with creatinine clearance rates in the same abnormal range as the GN patients, had lower mean PAI and a significantly higher mean scu-PA level. Normalization of scu-PA and t-PA:Ag levels during follow-up despite impaired renal function in GN, and the absence of depressed scu-PA levels in APKD suggest that the fibrinolytic abnormalities are independent of the impaired renal function per se, but associated with the acute stage of nephritis.

A Comparative Pharmacodynamic Study of Anti-Xa Activity To Evaluate the Accumulation Effect of Tinzaparin and Enoxaparin Given at Prophylactic Dose over 8 Days in Medical Elderly Patients with Impaired Renal Function.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4152-4152
Author(s):  
Isabelle Mahé ◽  
Claire Bal dit Sollier ◽  
Manvel Aghassarian ◽  
Karine Lacut ◽  
Jean-Jacques Heilmann ◽  
...  
Keyword(s):  
Renal Function ◽  
Body Weight ◽  
Elderly Patients ◽  
Creatinine Clearance ◽  
Impaired Renal Function ◽  
Accumulation Factor ◽  
Group Comparison ◽  
Prophylactic Dose ◽  
Accumulation Effect ◽  
The Mean

Abstract Rationale: LMWHs accumulate in patients with impaired renal function. As this accumulation depends on heparin chain length and subsequent reticulo-endothelial/renal elimination/catabolism LMWHs of different degree of depolymerisation (different distribution and length of heparin chains) should have different pharmacodynamic profile. Do these differences contribute to accumulation of LMWHs in case of renal insufficiency? Patients, methods and material: An open randomized parallel group trial has been conducted. The primary objective was to detect any accumulation effect of two LMWHs, enoxaparin and tinzaparin, after repeated administration of a prophylactic dose over 8 days in elderly patients (age >75 years) with impaired renal function (creatinine clearance between 20 and 50 ml/min)and body weight <65Kg. Patients were randomized in two parallel groups and received either enoxaparin (Lovenox®) 4000 IU, or tinzaparin (innohep®) 4500 UI. The anti-Xa and the anti-IIa activities have been measured on the 1st and the 8th days of treatment. Blood samples were taken at 0, 2, 4, 5, 6, 9, 12, 16, 24 hours after the injection of the study drug. The primary end point was the accumulation factor calculated as a ratio between the maximal Anti-Xa activity (Amax) observed on day 8 and the Amax observed on day 1. We also compared the values of the area under the time activity curve 0–24 hours post dosing (AUC0–24) and the residual activity 24 hours after the injection (A h24) observed on day 8 with the respective values observed on day 1. The laboratory analysis of pharmacodynamic data was blinded with regard to the allocation of treatment. Results: 55 patients have been included (mean age 87.9 ± 5.5 years). The mean renal creatinine clearance is 34.7± 11.4 ml/min; the mean body weight is 52.3± 8.6 kg. The main pharmacokinetic data are summarized in the table below. Discussion: In this pharmacodynamic study, a statistically significant accumulation effect was observed after 8 days of prophylactic treatment with enoxaparin but not with tinzaparin. These results reflect the impact of different chain lengths of LMWHs on elimination patterns in elderly patients with impaired renal function. Trials based on clinical endpoints should be conducted to evaluate the clinical relevance of these observations Peak level Amax D1 IU/mL (SD) Amax D8IU/mL (SD) Accumulation factor P-value (1): Within treatment comparison of D8 and D1 values by one sample t-test tinzaparin 0.44 (0.16) 0.46 (0.19) 1.05 0.2961 enoxaparin 0.67 (0.23) 0.67 (0.23) 1.22 <0.00011 Between group comparison 0.016 Trough level A h24 D1 IU/mL (SD) A h24 D8 IU/mL (SD) Ah24 D8 - Ah24 D1 tinzaparin 0.06 (0.04) 0.06 (0.05) 0.008 0.337 (1) enoxaparin 0.06 (0.06) 0.11 (0.11) 0.046 0.0271 Between group comparison 0.082

A Phase I Open-Label Trial To Determine the Pharmacokinetics of Glucarpidase in Subjects with Normal and Impaired Renal Function.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4450-4450
Author(s):  
Marc A. Phillips ◽  
Tim R. Auton ◽  
Suzanne B. Ward ◽  
William B. Smith ◽  
Guhan Balan
Keyword(s):  
Renal Function ◽  
Adverse Events ◽  
Renal Impairment ◽  
Creatinine Clearance ◽  
Normal Renal Function ◽  
Impaired Renal Function ◽  
Prolonged Exposure ◽  
The Body ◽  
Calculated Creatinine Clearance ◽  
The Mean

Abstract Methotrexate (MTX) is used in high doses in the treatment of cancers such as NHLs, leukemias and osteosarcoma. In some patients it produces renal damage which delays its elimination from the body. Prolonged exposure to high concentrations of MTX results in serious toxic effects. Glucarpidase (Voraxaze™, formerly carboxypeptidase G2) contains a recombinant enzyme which rapidly and predictably breaks down MTX in the blood within 15 minutes of administration. Multiple studies to date have evaluated glucarpidase as an intervention for patients at risk or experiencing toxicities related to MTX overexposure. Continuing studies seek to evaluate the use of glucarpidase in a planned way to circumvent toxicity and prevent prolonged hospitalization. The current study examined the pharmacokinetics of glucarpidase in subjects who had both normal and severely impaired renal function, similar to that of the intended patient population. Methods: Twelve male and female subjects participated in this study; 8 with normal renal function (calculated creatinine clearance >80 mL/min) and 4 with severely impaired renal function (calculated creatinine clearance <30 mL/min). Each subject received a single intravenous dose of glucarpidase 50 units/kg (equivalent to 114.5 μg/kg), infused over 5 min. Serum glucarpidase profiles were evaluated for all subjects using 7 mL blood samples collected at the following time points: pre-dose (prior to start of glucarpidase IV dose), end of 5-minute infusion, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 48, 72, and 96 hours following the start of the infusion. The study protocol was approved by the Crescent City Institutional Review Board IRB (New Orleans, LA) and all subjects gave their written informed consent prior to inclusion in the study. Results: The mean (SD) Cmax for glucarpidase in renally impaired subjects was 2.9 μg/mL (0.83), the mean half-life was 10.0 (2.1) h and mean AUC0-∞ was 24.5(9.4) μg.h/mL. Similar values were found in subjects with normal renal function (mean Cmax 3.1 μg/mL, mean t1/2 9.0 h and mean AUC0-∞ 23.4 μg.h/mL). No adverse events were recorded in the study. Conclusions: The results indicated little effect of renal impairment on the serum pharmacokinetics of glucarpidase. Evaluations of adverse events, clinical laboratory assessments, vital signs, ECGs, and physical examinations indicated that a single 50 unit/kg dose of glucarpidase was safe and well-tolerated when administered to subjects with normal renal function and subjects with severe renal impairment. PK parameters found in this study may be relevant to cancer patients treated with 50 units/kg glucarpidase, including those with MTX-induced renal toxicity.

scholarly journals Assessment of decrease in renal function associated with hypothyroidism

2021 ◽  
Vol 12 (1) ◽  
pp. 275-286
Author(s):  
Ayesha Ammar ◽  
Kahkashan Bashir Mir ◽  
Sadaf Batool ◽  
Noreen Marwat ◽  
Maryam Saeed ◽  
...  
Keyword(s):  
Renal Function ◽  
Confidence Interval ◽  
Creatinine Clearance ◽  
Confidence Intervals ◽  
Standard Error ◽  
Radioactive Iodine ◽  
T Test ◽  
Euthyroid State ◽  
Significant Difference ◽  
The Mean

Objective: Study was aimed to see the effects of hypothyroidism on GFR as a renal function. Material and methods: Total of Fifty-eight patients were included in the study. Out of those forty-eight patients were female and the rest were male. Out of fifty eight patients, fifty three patients were of thyroid cancer in which hypothyroidism was due to discontinuation of thyroxine before the administration of radioactive iodine for Differentiated thyroid cancer.Moreover, remaining five patients were post radioactive iodine treatment (for hyperthyroidism) hypothyroid. All of the patients were above eighteen years of age with TSH value > 30µIU/ml. Pregnant and lactating females were excluded.Renal function tests (urea/creatinine, creatinine clearance) and serum electrolytes followed by Tc-99m-DTPA renal scan for GFR assessment (GATES’ method) were carried out in all subjects twice during the study, One study during hypothyroid state (TSH > 30 µIU/ml) and other during euthyroid state (TSH between 0.4 to 4µ IU/ml). The results of Student’s t-test showed significant difference in renal functions (Urea, creatinine, creatinine clearance, GFR values) in euthyroid state and hypothyroid state (p-value <0.05). RESULTS: In case of creatinine the paired t test reveal the mean 1.014±0.428, with standard error of 0.669 within 95% confidence interval, for creatinine clearance 80.11±14.12 with standard error of 1.94 within 95% confidence intervals, for urea the mean 28±12.13 with standard error of 1.607 within 95% confidence intervals and for GFR for individual kidney is 38.056±8.56 with standard error of 1.3717 within 95% confidence interval. There was no difference in the outcome of the 2 groups. Conclusion: Hypothyroidism impairs renal function to a significant level and hence needs to be prevented and corrected as early as possible.

scholarly journals Associations between radiographic characteristics and change in renal function following partial nephrectomy using 24-hour creatinine clearance

2013 ◽  
Vol 5 (1) ◽  
pp. 45
Author(s):  
Rodney H. Breau ◽  
Aaron T.D. Clark ◽  
Chris Morash ◽  
Dean Fergusson ◽  
Ilias Cagiannos
Keyword(s):  
Renal Function ◽  
Creatinine Clearance ◽  
Partial Nephrectomy ◽  
Tumour Size ◽  
Multivariable Analysis ◽  
Function Change ◽  
Tumour Location ◽  
Function Preservation ◽  
The Mean ◽  
The Impact

Background: Radiographic characteristics may be associated withthe degree of renal function preservation following partial nephrectomy.The purpose of this study was to determine the impact ofpreoperative radiographic variables on change in renal functionusing 24-hour urine creatinine clearance (uCrCl).Methods: Patients with partial nephrectomy performed fromNovember 2003 to 2008 were enrolled in the study. Serum creatinineand 24-hour urine was collected preoperatively and at3, 6 and 12 months postoperatively. Computed tomography ormagnetic resonance imaging was used to determine tumour size,tumour location and renal volume.Results: Of the 36 patients, median age was 62 (range 30-78) and21 (58%) were male. The mean tumour diameter was 2.8±1.4 cm.Twenty-two (61%) tumours were located at the renal pole and11 (31%) were endophytic. Overall, mean preoperative uCrClwas 88.8±34.2 mL/min and mean postoperative uCrCl was82.8±33.6 mL/min (6.8%; p < 0.01). On multivariable analysis,no single characteristic was associated with a clinically prohibitivedecrease in renal function (-9.4% if endophitic, p = 0.06; -0.57%per cm diameter, p = 0.73; and -6.9% if located at the renal pole,p = 0.15). The total renal volume was also not significantly associatedwith renal function change (-1.1% per 100 cc, p = 0.86).Interpretation: Preoperative radiographic characteristics seem tobe associated with small changes in renal function following partialnephrectomy. These data support renal functional benefits of partialnephrectomy regardless of tumour size and location.

Risk Factors for Early Mortality in U.S. Peritoneal Dialysis Patients: Impact of Residual Renal Function

2002 ◽  
Vol 22 (3) ◽  
pp. 371-379 ◽  
Author(s):  
◽  
Michael V. Rocco ◽  
Diane L. Frankenfield ◽  
Barbara Prowant ◽  
Pamela Frederick ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Renal Function ◽  
Peritoneal Dialysis ◽  
Serum Albumin ◽  
Creatinine Clearance ◽  
Residual Renal Function ◽  
Chronic Peritoneal Dialysis ◽  
Dialysis Patients ◽  
The Mean

Background Potential risk factors for 1-year mortality, including the peritoneal component of dialysis dose, residual renal function, demographic data, hematocrit, serum albumin, dialysate-to-plasma creatinine ratio, and blood pressure, were examined in a national cohort of peritoneal dialysis patients randomly selected for the Centers for Medicare and Medicaid Services End-Stage Renal Disease (ESRD) Core Indicators Project. Methods The study involved retrospective analysis of a cohort of 1219 patients receiving chronic peritoneal dialysis who were alive on December 31, 1996. Results During the 1-year follow-up period, 275 patients were censored and 200 non censored patients died. Among the 763 patients who had at least one calculable adequacy measure, the mean [± standard deviation (SD)] weekly Kt/V urea was 2.16 ± 0.61 and the mean weekly creatinine clearance was 66.1 ± 24.4 L/1.73 m2. Excluding the 365 patients who were anuric, the mean (±SD) urinary weekly Kt/V urea was 0.64 ± 0.52 (median: 0.51) and the mean (±SD) urinary weekly creatinine clearance was 31.0 ± 23.3 L/1.73 m2 (median: 26.3 L/1.73 m2). By Cox proportional hazard modeling, lower quartiles of renal Kt/V urea were predictive of 1-year mortality; lower quartiles of renal creatinine clearance were of borderline significance for predicting 1-year mortality. The dialysate component of neither the weekly creatinine clearance nor the weekly Kt/V urea were predictive of 1-year mortality. Other predictors of 1-year mortality ( p < 0.01) included lower serum albumin level, older age, and the presence of diabetes mellitus as the cause of ESRD, and, for the creatinine clearance model only, lower diastolic blood pressure. Conclusion Residual renal function is an important predictor of 1-year mortality in chronic peritoneal dialysis patients.

Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function

2007 ◽  
Vol 97 (04) ◽  
pp. 581-586 ◽  
Author(s):  
Manvel Aghassarian ◽  
Ludovic Drouet ◽  
Claire dit-Sollier ◽  
Karine Lacut ◽  
Jean-Jacques Heilmann ◽  
...  
Keyword(s):  
Renal Function ◽  
Body Weight ◽  
Elderly Patients ◽  
Creatinine Clearance ◽  
Impaired Renal Function ◽  
The Body ◽  
Accumulation Factor ◽  
Renal Elimination ◽  
Prophylactic Dose ◽  
Accumulation Effect

SummaryLow-molecular-weight heparins (LMWHs) accumulate in patients with impaired renal function. As this accumulation depends on heparin chain length and subsequent reticulo-endothelial/renal elimination, LMWHs might have different pharmacodynamic profiles. The primary objective was to examine if any accumulation effect of two LMWHs, enoxaparin and tinzaparin, occurred after repeated administration of a prophylactic dose over eight days in elderly patients (age >75 years) with creatinine clearance between 20 and 50 ml/min and body weight <65Kg. Patients were openly randomized to two groups (enoxaparin 4,000 IU or tinzaparin 4,500 IU once daily). Anti-Xa was measured on day 1 and day 8. Blood samples were taken at 0, 2, 4, 5, 6, 9, 12, 16 and 24 hours. The primary end point was the accumulation factor calculated as a ratio between the maximal anti-Xa activity on day 1and day 8. Fifty-five patients were included (mean age 87.9 ± 5.5 ).The creatinine clearance was 34.7 ± 11.4 ml/min; the body weight was 52.3 ± 8.6 kg. The accumulation factor defined was not significant for tinzaparin (1.05, p=0.29) while it was significantly enhanced for enoxaparin (1.22, p <0.0001). In this pharmacodynamic study performed in elderly patients with impaired renal function, a statistically significant accumulation effect was observed after eight days of prophylactic treatment with enoxaparin but not with tinzaparin, which are two LMWHs with different chain lengths. Trials based on clinical end points should be conducted to evaluate the clinical relevance of these observations.

Assessment of possible nephrotoxicity from iohexol in patients with normal and impaired renal function

1998 ◽  
Vol 39 (4) ◽  
pp. 362-367 ◽  
Author(s):  
S. Lundqvist ◽  
G. Holmberg ◽  
G. Jakobsson ◽  
F. Lithner ◽  
K. Skinningsrud ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Renal Function ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Creatinine Clearance ◽  
Impaired Renal Function ◽  
Urine Protein ◽  
Urine Protein Excretion ◽  
Protein Excretion ◽  
Patients With Diabetes

Purpose: To evaluate the possible nephrotoxic effects of iohexol in patients with normal and impaired renal function. Material and Methods: A prospective urographic study using iohexol (50 ml, 300 mg I/ml) was performed in 100 patients, 63 with impaired renal function (IRF) and 37 with normal renal function (NRF). The group included 24 patients with diabetes mellitus, 17 of them with IRF. Renal function parameters and adverse events were recorded for one week after the urography. Results: There were no significant changes in serum creatinine, creatinine clearance, or β-2-microglobulin. The 24-h urine protein excretion showed a statistically significant increase in patients with NRF as well as in patients with IRF. Nine patients experienced adverse events but none of them required any treatment. Conclusion: Iohexol was tolerated well in patients with NRF and in patients with IRF without significant overall nephrotoxic effects. Some minor adverse events were recorded.

Lenalidomide Plus High-Dose Dexamethasone Provides Improved Overall Survival Compared to High-Dose Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma (MM): Results of 2 Phase III Studies (MM-009, MM-010) and Subgroup Analysis of Patients with Impaired Renal Function.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3547-3547 ◽  
Author(s):  
Donna Weber ◽  
Michael Wang ◽  
Christine Chen ◽  
Andrew Belch ◽  
Edward A. Stadtmauer ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Renal Function ◽  
Creatinine Clearance ◽  
Subgroup Analysis ◽  
Impaired Renal Function ◽  
Phase Iii ◽  
High Dose ◽  
High Dose Dexamethasone ◽  
Duration Of Response

Abstract Lenalidomide is a novel, orally administered immunomodulatory drug (IMiD) that has single-agent activity against multiple myeloma (MM) and additive effects when combined with dexamethasone. We have previously reported improved response (OR), time to progression (TTP) and overall survival (OS) with lenalidomide-dexamethasone (Len-Dex) compared to dexamethasone-placebo (Dex) based on the results of 2 phase III trials (MM-009, North American, 353 pts; MM-010, Europe, Australia, and Israel, 351 pts). In both trials patients with relapsed or refractory MM not resistant to dexamethasone, were treated with dexamethasone 40 mg daily on days 1–4, 9–12, and 17–20 every 28 days and were randomized to receive either lenalidomide 25 mg daily orally on days 1–21 every 28 days or placebo. Beginning at cycle 5, Dex was reduced to 40 mg daily on days 1–4 only, every 28 days. Patients were also stratified with respect to B2M (≤2.5 vs. > 2.5 mg/mL), prior stem cell transplant (none vs. ≥ 1), and number of prior regimens (1 vs > 1). At a median follow-up from randomization of 17.1 mos (MM-009) and 16.5 mos (MM-010), both studies continue to show significant improvement with Len-Dex compared to Dex in OR (MM-009: 61% vs 20.5%, p<.001; MM-010: 59.1% vs. 24%, p<.001, respectively), TTP (MM-009: 11.1mos vs. 4.7mos, p<.001; MM-010: 11.3mos vs. 4.7mos, p<.001, respectively), and OS (MM-009: 29.6mos vs. 20.5mos, p<.001; MM-010: not estimable vs 20.6mos, p<.001, respectively). Pooled data from both trials demonstrates a significant improvement in duration of response for pts achieving ≥ PR with 122/216 pts (56.5%) who received Len-Dex continuing in remission (med. duration of response not reached but > 68.1 wks) compared to only 22/76 pts (28.9%) treated with dexamethasone alone (med. duration of response 22.1 wks, p<.001). An additional subgroup analysis was performed on pts with impaired creatinine clearance (cr cl). No significant difference in response rate, TTP, or OS was noted for patients with cr cl above or below 50 ml/min who were treated with Len-Dex, but for 16 pts with cr cl <30ml/min, med. TTP and OS was shorter than for those with cr cl >30ml/min, but still significantly higher than for pts treated with Dex. Grade 3–4 thrombocytopenia was significantly higher in pts with impaired renal function (<50ml/min, 13.8%; >50ml/min 4.6%, p<.01; <30ml/min, 18.8%, >30 ml/min, 5.5%, p<.05), but there was no difference for G3–4 neutropenia at either cutoff. Phase I–II evaluation to establish appropriate dosing in pts with cr cl < 30ml/min, particularly with respect to thrombocytopenia is warranted, but should not underscore improved OR, TTP, and OS for pts treated with Len-Dex regardless of creatinine clearance.

Pharmacokinetics of lenalidomide in subjects with various degrees of renal function

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2520-2520
Author(s):  
N. Chen ◽  
H. Lau ◽  
L. Kong ◽  
J. Zeldis ◽  
R. Knight ◽  
...  
Keyword(s):  
Renal Function ◽  
Creatinine Clearance ◽  
Strongly Correlated ◽  
Pooled Data ◽  
Safety Parameters ◽  
Immunomodulatory Drug ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage ◽  
Initial Starting

2520 Background: Lenalidomide is a novel oral immunomodulatory drug approved for treating myelodysplastic syndrome (MDS) and multiple myeloma (MM). As unchanged lenalidomide is eliminated predominantly by urinary excretion, the present study investigated the effect of renal impairment (RI) on pharmacokinetics (PK) of lenalidomide. Results were used to refine initial dosing recommendations based on a subject’s estimated creatinine clearance. Methods: The study was conducted at 3 clinical centers. Thirty male and female subjects aged 39–76 years were stratified into 5 groups based on their creatinine clearance (CLCr) values: normal renal function (NRF) (CLCr > 80 mL/min; N = 7), mild RI (50 = CLCr = 80 mL/min; N = 5), moderate RI (30 = CLCr < 50 mL/min; N = 6), severe RI (CLCr < 30 mL/min, but not on dialysis; N = 6), and end stage renal disease (ESRD, requiring dialysis; N = 6). Subjects with NRF, mild, moderate or severe RI received a single 25-mg oral dose of lenalidomide. Subjects with ESRD received 2 single 25 mg doses which were separated by 7–10 days: one dose on a non-dialysis day and the other dose 3 hours before a 4-hour haemodialysis. Assessments included PK and safety parameters. Results: All subjects completed the study. Total and renal clearance of lenalidomide were strongly correlated with CLCr (R > 0.9, p < 0.01). As a result, AUC8 increased with decreasing CLCr. The mean difference in AUC8 between NRF and mild RI was < 20%. Compared with the pooled data from NRF and mild RI groups, mean AUC8 increased approximately 140% in moderate RI, 240% in severe RI, and 360% in ESRD (off dialysis). There was no correlation between Cmax or Tmax and CLCr. Approximately 10% of the dose was recovered in the dialysate of subjects with ESRD. Protein binding of lenalidomide was not markedly affected by RI (∼35 - 44%). The drug was well tolerated. On the basis of these data, recommendations for initial starting doses were made ( Table below). Conclusions: Lenalidomide dosage adjustment should be considered for patients with CLCr < 50 mL/min. [Table: see text] No significant financial relationships to disclose.

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