scholarly journals Limited Performance of Estimated Total Kidney Volume for Follow-up of ADPKD

2021 ◽  
Author(s):  
Nathalie Demoulin ◽  
Victoria Nicola ◽  
Nicolas Michoux ◽  
Valentine Gillion ◽  
Thien Anh Ho ◽  
...  
Keyword(s):  
Kidney Volume ◽  
Total Kidney Volume

scholarly journals SO093LONGITUDINAL DATA ON TREATMENT DURATION AND COMPLIANCE FROM AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE CLINICAL TRIALS WITH TOLVAPTAN

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xiaolei Zhou ◽  
Diana Garbinsky ◽  
John Ouyang ◽  
Eric Davenport ◽  
Indra Agarwal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Treatment Duration ◽  
Treatment Time ◽  
Treatment Compliance ◽  
Kidney Volume ◽  
Total Kidney Volume ◽  
Treatment Gaps ◽  
Clinical Trial Program

Abstract Background and Aims : Observation of impactful clinical outcomes in a clinical trial setting for ADPKD is challenging due to the life-long progressive nature of ADPKD and longer-term associated outcomes of interest in this population (e.g., renal function decline, cardiovascular events, and mortality). Since 2004, the tolvaptan (TOL) clinical trial program enrolled subjects in multiple clinical studies with the opportunity to enroll in subsequent clinical trials for treatment and outcomes evaluation. Method : Data from 6 ADPKD studies (protocols 156-04-250, 156-04-251, 156-06-260, 156-09-284, 156-09-290, 156-08-271) were pooled and evaluated over time for overall treatment duration, treatment time, and treatment gaps. Treatment duration for the individual clinical trials ranged from 1 week to up to 3 years. Results : Overall, 1,437 subjects received TOL in these ADPKD clinical trials. For these subjects, the mean overall treatment duration was 4.1 years (3.8 years on treatment) with a maximum of 9.7 years (9.0 years on treatment). In this cohort, 513 subjects (35.7%) received TOL treatment for more than 5 years. Mean treatment compliance was 94.1%. Overall, 723 subjects (50.3%) received TOL treatment in ≥2 trials, with a median treatment gap duration between trials of 0.1 years (maximum, 5.6 years). At least 7 years of follow-up data are available for estimated glomerular filtration rate in 241 subjects (mean at baseline, 78.6 mL/min/1.73m2) and for total kidney volume in 130 subjects (mean at baseline, 1,816.9 mL). Conclusion : This analysis provides longitudinal follow-up over an extended timeframe in a large number of subjects treated with TOL, with the greatest number of subjects being enrolled in clinical trials enriched for rapidly progressing ADPKD. Treatment compliance over years was reasonably good despite treatment gaps.

scholarly journals Urine and Plasma Osmolality in Patients with Autosomal Dominant Polycystic Kidney Disease: Reliable Indicators of Vasopressin Activity and Disease Prognosis?

2015 ◽  
Vol 41 (3) ◽  
pp. 248-256 ◽  
Author(s):  
Niek F. Casteleijn ◽  
Debbie Zittema ◽  
Stephan J.L. Bakker ◽  
Wendy E. Boertien ◽  
Carlo A. Gaillard ◽  
...  
Keyword(s):  
Water Intake ◽  
Plasma Osmolality ◽  
Urine Osmolality ◽  
Kidney Volume ◽  
Polycystic Kidney ◽  
Estimated Gfr ◽  
Total Kidney Volume ◽  
Autosomal Dominant Polycystic Kidney ◽  
Crude Analysis

Background: Vasopressin plays an essential role in osmoregulation, but has deleterious effects in patients with ADPKD. Increased water intake to suppress vasopressin activity has been suggested as a potential renoprotective strategy. This study investigated whether urine and plasma osmolality can be used as reflection of vasopressin activity in ADPKD patients. Methods: We measured urine and plasma osmolality, plasma copeptin concentration, total kidney volume (TKV, by MRI) and GFR (125I-iothalamate). In addition, change in estimated GFR (eGFR) during follow-up was assessed. Results: Ninety-four patients with ADPKD were included (56 males, age 40 ± 10, mGFR 77 ± 32 ml/min/1.73 m2, TKV 1.55 (0.99-2.40) l. Urine osmolality, plasma osmolality and copeptin concentration were 420 ± 195, 289 ± 7 mOsmol/l and 7.3 (3.2-14.6) pmol/l, respectively. Plasma osmolality was associated with copeptin concentration (R = 0.54, p < 0.001), whereas urine osmolality was not (p = 0.4). In addition, urine osmolality was not associated with TKV (p = 0.3), in contrast to plasma osmolality (R = 0.52, p < 0.001) and copeptin concentration (R = 0.61, p < 0.001). Fifty-five patients were followed for 2.8 ± 0.8 years. Baseline plasma and urine osmolality were not associated with change in eGFR (p = 0.6 and p = 0.3, respectively), whereas baseline copeptin concentration did show an association with change in eGFR, in a crude analysis (St. β = -0.41, p = 0.003) and also after adjustment for age, sex and TKV (St. β = -0.23, p = 0.05). Conclusions: These data suggest that neither urine nor plasma osmolality are valid measures to identify ADPKD patients that may benefit from increasing water intake. Copeptin appears a better alternative for this purpose.

scholarly journals The Natural Course of Total Kidney Volume in Patients with Autosomal Dominant Polycystic Kidney Disease undergoing Hemodialysis

2021 ◽  
Vol 36 (2) ◽  
pp. 109-115
Author(s):  
Ye Na Kim ◽  
Yeonsoon Jung ◽  
Ho Sik Shin ◽  
Hark Rim ◽  
Jung Gu Park ◽  
...  
Keyword(s):  
Autosomal Dominant ◽  
Kidney Volume ◽  
Polycystic Kidney ◽  
Total Kidney Volume ◽  
Change Rate ◽  
The Mean ◽  
Autosomal Dominant Polycystic Kidney ◽  
Group 2 ◽  
Group 1

Objectives: The natural course of native kidneys after hemodialysis initiation in patients with autosomal dominant polycystic kidney disease (ADPKD) remains poorly understood.Methods: We measured the total volumes of native kidneys in 12 patients who had at least one enhanced computed tomography (CT) image both before and after initiation of hemodialysis (group 1) and in 18 patients who had no image before dialysis but more than two images after dialysis (group 2). In patients with images, the last image was used for analysis only after dialysis.Results: The mean total kidney volume (TKV) (± SD) before hemodialysis initiation was 3132 ± 1413 mL and the mean TKV of the last image was 3047 ± 1323 mL in group 1. The mean TKV change rate (%) was - 5.2 ± 27.4% (P > 0.05) during follow-up of 3.9 ± 1.9 years in group 1. The mean TKV change rate was 2.8 ± 34.4% (P > 0.05) in group 2. The follow-up period after dialysis initiation ranged from 4.2 ± 4.7 to 8.0 ± 5.2 years.Conclusions: The results suggest that the TKV of native polycystic kidneys decreases substantially after hemodialysis initiation. This reduction occurs mainly during the early post-hemodialysis period and followed by a slow enlargement of TKV.

scholarly journals Soluble Urokinase Plasminogen Activator Receptor and Decline in Kidney Function in Autosomal Dominant Polycystic Kidney Disease

2019 ◽  
Vol 30 (7) ◽  
pp. 1305-1313 ◽  
Author(s):  
Salim S. Hayek ◽  
Douglas P. Landsittel ◽  
Changli Wei ◽  
Martin Zeier ◽  
Alan S.L. Yu ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Kidney Volume ◽  
Polycystic Kidney ◽  
Urokinase Plasminogen Activator Receptor ◽  
Total Kidney Volume ◽  
Progressive Decline ◽  
Ckd Stage ◽  
Plasminogen Activator Receptor ◽  
Autosomal Dominant Polycystic Kidney

BackgroundLevels of soluble urokinase plasminogen activator receptor (suPAR), an inflammation marker, are strongly predictive of incident kidney disease. Patients with autosomal dominant polycystic kidney disease (ADPKD) experience progressive decline in renal function, but rates of decline and outcomes vary greatly. Whether suPAR levels are predictive of declining kidney function in patients with ADPKD is unknown.MethodsWe assessed suPAR levels in 649 patients with ADPKD who underwent scheduled follow-up for at least 3 years, with repeated measurements of height-adjusted total kidney volume and creatinine-derived eGFR. We used linear mixed models for repeated measures and Cox proportional hazards to characterize associations between baseline suPAR levels and follow-up eGFR or incident ESRD.ResultsThe median suPAR level was 2.47 ng/ml and median height-adjusted total kidney volume was 778, whereas mean eGFR was 84 ml/min per 1.73 m2. suPAR levels were associated with height-adjusted total kidney volume (β=0.02; 95% confidence interval, 0.01 to 0.03), independent of age, sex, race, hypertension, and eGFR. Patients in the lowest suPAR tertile (<2.18 ng/ml) had a 6.8% decline in eGFR at 3 years and 22% developed CKD stage 3, whereas those in the highest tertile (suPAR>2.83 ng/ml) had a 19.4% decline in eGFR at 3 years and 68% developed CKD stage 3. suPAR levels >2.82 ng/ml had a 3.38-fold increase in the risk of incident ESRD.ConclusionssuPAR levels were associated with progressive decline in renal function and incident ESRD in patients with ADPKD, and may aid early identification of patients at high risk of disease progression.

scholarly journals Urinary Lithogenic Risk Profile in ADPKD Patients Treated with Tolvaptan

2020 ◽  
Vol 15 (7) ◽  
pp. 1007-1014 ◽  
Author(s):  
Matteo Bargagli ◽  
Nasser A. Dhayat ◽  
Manuel Anderegg ◽  
Mariam Semmo ◽  
Uyen Huynh-Do ◽  
...  
Keyword(s):  
Uric Acid ◽  
Calcium Oxalate ◽  
Stone Formation ◽  
Multivariable Analysis ◽  
Risk Profile ◽  
Kidney Volume ◽  
Acid Excretion ◽  
Total Kidney Volume ◽  
Net Acid Excretion

Background and objectivesNephrolithiasis is a common health problem in autosomal dominant polycystic kidney disease (ADPKD) and significantly contributes to patient morbidity. Recently, Tolvaptan has been introduced for the treatment of ADPKD, but whether it is associated with alterations of the urinary lithogenic risk profile remains unknown.Design, setting, participants, & measurementsWe conducted an analysis of participants enrolled in the Bern ADPKD registry, a prospective observational cohort study. Twenty-four-hour urine analyses were performed at baseline and then at yearly follow-ups. Relative supersaturation ratios for calcium oxalate, brushite, and uric acid were calculated with the program EQUIL2. Unadjusted and multivariable mixed-effects linear regression models, adjusted for age, sex, body mass index, eGFR, net acid excretion, and height-adjusted total kidney volume, were used to assess the association of Tolvaptan with urinary parameters relevant for kidney stone formation. The maximum individual follow-up time was 3 years, median follow-up time 1.9 years, and cumulative follow-up time 169 years.ResultsIn total, 125 participants (38 with and 87 without Tolvaptan treatment) were included in the analysis. In multivariable analysis, Tolvaptan treatment was associated [adjusted estimate of the difference between Tolvaptan and no Tolvaptan; 95% confidence interval (CI)] with lower urine relative supersaturation ratios for calcium oxalate (−0.56; 95% CI, −0.82 to −0.3; P<0.001), brushite (−0.33; 95% CI, −0.54 to −0.11; P=0.004), and uric acid (−0.62; 95% CI, −0.88 to −0.37; P<0.001), and with higher urine citrate in mmol/mmol creatinine per day (0.25; 95% CI, 0.05 to 0.46; P=0.02) and calcium in mmol/mmol creatinine per day (0.31; 95% CI, 0.09 to 0.53; P=0.006) excretion. In addition, Tolvaptan treatment was associated with lower net acid excretion in mEq/mmol creatinine per day (−0.54; 95% CI, −0.90 to −0.17; P=0.004) and higher net gastrointestinal alkali absorption in mEq/mmol creatinine per day (0.57; 95% CI, 0.26 to 0.88; P<0.001).ConclusionsTolvaptan treatment is associated with a significantly improved urinary lithogenic risk profile in patients with ADPKD.

P1812DOES THE TOTAL KIDNEY VOLUME REFLECT ALPORT SYNDROME PROGRESSION?

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
MARINA AKSENOVA ◽  
Natalia Konkova ◽  
Tatjana Lepaeva ◽  
Tatjana Nikishina ◽  
Oxana Piruzeeva ◽  
...  
Keyword(s):  
Alport Syndrome ◽  
The Body ◽  
Kidney Volume ◽  
Loss Of Function ◽  
Renal Disease Progression ◽  
Total Kidney Volume ◽  
Stage 4 ◽  
Ckd Stage ◽  
And Gender

Abstract Background and Aims The kidney volume can reflect kidney function and predict renal disease progression. The aim of the study was to define the clinical significance of kidney volume in children with Alport syndrome (AS). Method The medical records were obtained from 86 children (age Me 8(5;11) years; 50M/36F) with genetically (n=78) and morphologically (n=8) confirmed AS; follow-up Me 4(2;6) years. Albuminuria (Alb), proteinuria (Pr), nephrotic proteinuria (nPr) and decreased eGFR were defined as urine Alb&gt;30 mg/gr Cr, Pr≥100 mg/m2/day, Pr≥960 mg/m2/day and eGFR&lt;90 ml/min/1,73m2, respectively. The Body Superficial Area Related Total Kidney Volume (BSARTKV) was calculated as relation of US kidney volume to BSA: BSARTKV[ml/m2]=(L*W*D*π/6)/BSA and compared with normal volume range (Th.Scholbach, D.Weitzel, 2012). Results The renal volume ≥95‰ was revealed in ½ and ¾ of children at initial and last evaluation, respectively (0.51 vs 0.76, p&gt;0.05); two boys (q=0.02) with CKD stage 4 had a BSARTKV ≤10‰ at the last presentation. BSARTKV correlated with age (r=0.3, p&lt;0.05), mean blood pressure percentile (r=-0,22, p&lt;0,05), Alb (r=0.25, p&lt;0.05), Pr (r=0.4, p&lt;0,001) and eGFR (r=0.23, p&lt;0.05). No correlation was found between BSARTKV and birth weight and gender. Each 1SD (23.5 ml/m2) increase in BSARTKV was related with higher eGFR: OR=6.7 (95%CI 3.51;8.69, p&lt;0,001). The children with nPr and eGFR&gt;35 ml/min/1,73m2 had enlarged kidneys: OR=30.75(95%CI 2.56;369, p&lt;0,001); the patients with eGFR≤35 ml/min/1,73m2 had small BSARTKV: OR=167 (95%CI 10.4;2681.3, p&lt;0,0001). Conclusion The kidney volume reflects the progression of nephropathy in AS. Probably, an increased renal mass compensates decreased glomerular function, whereas small kidney volume represents the loss of function of most nephrons.

scholarly journals Effect of tolvaptan in Japanese patients with autosomal dominant polycystic kidney disease: a post hoc analysis of TEMPO 3:4 and TEMPO Extension Japan

2021 ◽  
Author(s):  
Satoru Muto ◽  
Tadashi Okada ◽  
Yoshiyuki Shibasaki ◽  
Tatsuki Ibuki ◽  
Shigeo Horie
Keyword(s):  
Kidney Disease ◽  
Polycystic Kidney Disease ◽  
Autosomal Dominant ◽  
Kidney Volume ◽  
Polycystic Kidney ◽  
Efficacy Evaluation ◽  
Total Kidney Volume ◽  
Post Hoc Analysis ◽  
Autosomal Dominant Polycystic Kidney ◽  
Post Hoc

Abstract Background Autosomal dominant polycystic kidney disease (ADPKD) is a progressive condition that eventually leads to end-stage renal disease. A phase 3 trial of tolvaptan (TEMPO 3:4; NCT00428948) and its open-label extension (TEMPO Extension Japan: TEMPO-EXTJ; NCT01280721) were conducted in patients with ADPKD. In this post hoc analysis, effects on renal function and the safety profile of tolvaptan were assessed over a long-term period that included the 3-year TEMPO 3:4 and the approximately 3-year TEMPO-EXTJ trials. Methods Patients from Japanese trial sites who completed TEMPO 3:4 were offered participation in TEMPO-EXTJ. Patients whose efficacy parameters were measured at year 2 in TEMPO-EXTJ for efficacy evaluation were included. The annual slope of the estimated glomerular filtration rate (eGFR) and growth in total kidney volume (TKV) were analyzed. Results In patients who received tolvaptan in TEMPO 3:4 and TEMPO-EXTJ, the annual slope of eGFR (mL/min/1.73 m2) was − 3.480 in TEMPO 3:4 and − 3.417 in TEMPO-EXTJ, with no apparent effect of an approximately 3.6-month off-treatment interval between the two trials. In patients who received a placebo in TEMPO 3:4 before initiating tolvaptan in TEMPO-EXTJ, the slope of eGFR was significantly less steep from TEMPO 3:4 (− 4.287) to TEMPO-EXTJ (− 3.364), a difference of 0.923 (P = 0.0441). Conclusion The TEMPO-EXTJ trial supports a sustained beneficial effect of tolvaptan on eGFR. In patients who received a placebo in TEMPO 3:4, initiation of tolvaptan in TEMPO-EXTJ was associated with a significant slowing of eGFR decline.

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