Efficacy and safety of once-monthly risedronate in osteoporosis subjects with mild-to-moderate chronic kidney disease: a post hoc subgroup analysis of a phase III trial in Japan

2018 ◽  
Vol 37 (4) ◽  
pp. 730-740
Author(s):  
Toshitsugu Sugimoto ◽  
Daisuke Inoue ◽  
Masayuki Maehara ◽  
Ichiro Oikawa ◽  
Takashi Shigematsu ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Subgroup Analysis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Trial ◽  
Moderate Chronic Kidney Disease ◽  
Post Hoc

scholarly journals Efficacy and Safety of Tanshinone for Chronic Kidney Disease: A Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Yao Zhou ◽  
Shi-min Jiang ◽  
Li Li ◽  
Ying Wang ◽  
Lei Ding ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Treatment Group ◽  
Kidney Disease ◽  
Subgroup Analysis ◽  
Protein Level ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Efficacy And Safety ◽  
Urine Protein

Objective. To systematically evaluate the efficacy and safety of tanshinone for chronic kidney disease (CKD). Methods. Randomized controlled trials (RCTs) on the treatment of CKD using tanshinone were searched using 4 Chinese databases (China National Knowledge Infrastructure (CNKI), Value In Paper (VIP), Wanfang, and Chinese Biology Medicine (CBM)) and 3 English databases (PubMed, Cochrane Library, and Excerpta Medica Database (Embase)). The results included data on blood urine nitrogen (BUN), serum creatinine (Scr), glomerular filtration rate (GFR), 24 h urine protein, microalbuminuria (mALB), β2-macroglobulin (β2-MG), cystatin C (CysC), and safety events. The data were analyzed using Revman 5.3 and Stata 12.0 software. Results. Twenty-one studies were entered into this meta-analysis, which involved 1857 patients including 954 cases from the tanshinone treatment group and 903 cases from the control group. BUN levels in the tanshinone treatment group were significantly reduced compared with the control (standardized mean difference (SMD) = −0.65, 95% confidence interval (CI): −0.81 to −0.49, p<0.01). In addition, subgroup analysis indicated that tanshinone had a significant effect in reducing Scr levels at 14, 21, and 28 days. Scr levels in the tanshinone treatment group were significantly reduced compared with the control group (SMD = −1.40, 95% CI: −2.09 to −0.71, p<0.01); subgroup analysis based on treatment time also yielded the same results. GFR in the tanshinone treatment group was better than that in the control group (SMD = 0.83, 95% CI: 0.59 to 1.07, p<0.01). In terms of urine protein levels, 24 h urine protein level, mALB, and β2-MG of CKD patients were reduced to some degree compared with controls, and CysC levels in the tanshinone treatment group were also significantly reduced compared with the control group (SMD = −0.24, 95% CI: −0.44 to −0.03, p<0.05). Safety in the tanshinone treatment group did not differ significantly from that of the control group (risk ratio (RR) = 7.78, 95% CI: 0.99 to 61.05, p>0.05). Conclusion. This meta-analysis showed that tanshinone could control urine protein level in CKD patients, improve kidney function, and delay the evolution of CKD without significant side effects. However, the results were limited and should be interpreted with caution because of the low quality of the included studies. In the future, more rigorous clinical trials need to be conducted to provide sufficient and accurate evidence.

scholarly journals Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Shubhadeep D. Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Darbepoetin Alfa ◽  
Phase Iii ◽  
Phase Iii Trial

Lenalidomide (LEN)-melphalan-prednisone induction followed by LEN maintenance (MPR-R) in newly diagnosed multiple myeloma (NDMM) elderly patients (Pts) with moderate renal impairment (RI): MM-015 trial post-hoc analysis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8544-8544
Author(s):  
John V. Catalano ◽  
Antonio Palumbo ◽  
Katja C. Weisel ◽  
Meletios A. Dimopoulos ◽  
Michel Delforge ◽  
...  
Keyword(s):  
Phase Iii ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Pivotal Phase ◽  
Phase Iii Trial ◽  
Post Hoc Analysis ◽  
Negative Prognostic Factor ◽  
Starting Dose ◽  
Post Hoc ◽  
Clinical Trial Information

8544 Background: The MM-015 pivotal phase III trial showed significant PFS benefit for MPR-R (31 mos) vs. MPR (14 mos) or MP (13 mos; both p < 0.001) followed by placebo in NDMM pts aged ≥ 65 years. As NDMM pts with RI have poor prognosis, this retrospective analysis studied the efficacy and safety of MPR-R in pts with creatinine clearance (CrCl) < 60 mL/min. Methods: LEN starting dose for induction/maintenance was 10 mg/day (D1–21 of a 28-day cycle). Dose adjustments were not recommended for pts with RI. CrCl was calculated using the Cockcroft-Gault equation. Pts with severe RI (serum Cr > 2.5 mg/dL [221 μmol/L]) were excluded from the trial. Results: Pts with CrCl < 60 mL/min (median 47, interquartile range [IQR] 38–55) were included in this analysis: 51% MPR-R, 45% MPR, and 49% MP. Median PFS was significantly higher with MPR-R (26 mos [95% CI 14–48]) vs. MPR (13 mos [95% CI 12–15]) or MP (14 mos [95% CI 12–16]; both p < 0.001). In a Cox proportional model of PFS, CrCl < 60 mL/min was not identified as a negative prognostic factor (p = 0.69). The most common Gr 4 adverse events (AEs) were hematologic and occurred predominantly during induction and are shown in the Table for pts with or without moderate RI. The number of deaths on study was similar: 10% (MPR-R), 7% (MPR), and 8% (MP); deaths associated with RI or disease progression were reported in ≤ 1% of pts with RI across the arms. Conclusions: The benefit of continuous LEN treatment with MPR-R is not compromised in NDMM pts with moderate RI, consistent with the overall trial results. CrCl and AEs should be monitored closely in this population. Clinical trial information: NCT00405756. [Table: see text]

scholarly journals Correction to: Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Shubhadeep D. Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Darbepoetin Alfa ◽  
Phase Iii ◽  
Phase Iii Trial

Following publication of the original article [1], the authors reported errors in the presentation of Tables 2, 4 and 5.

scholarly journals Efficacy and safety of bivalirudin in coronary artery disease patients with mild to moderate chronic kidney disease: Meta-analysis

2018 ◽  
Vol 71 (5) ◽  
pp. 494-504 ◽  
Author(s):  
Xiaofang Zeng ◽  
A. Michael Lincoff ◽  
Stefanie Schulz-Schüpke ◽  
Philippe Gabriel Steg ◽  
Yedid Elbez ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Chronic Kidney Disease ◽  
Coronary Artery ◽  
Kidney Disease ◽  
Meta Analysis ◽  
Efficacy And Safety ◽  
Artery Disease ◽  
Moderate Chronic Kidney Disease

scholarly journals Efficacy and safety of direct-acting antiviral agents for HCV in mild-to-moderate chronic kidney disease

2020 ◽  
Vol 40 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Ezequiel Ridruejo ◽  
Rebeca Garcia-Agudo ◽  
Manuel Mendizabal ◽  
Sami Aoufi-Rabih ◽  
Vivek Dixit ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Antiviral Agents ◽  
Efficacy And Safety ◽  
Direct Acting Antiviral ◽  
Moderate Chronic Kidney Disease ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents

P0880EFFICACY AND SAFETY OF SEVELAMER CARBONATE IN NON-DIALYSIS HYPERPHOSPHATEMIA PATIENTS: A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP STUDY FOR THE TREATMENT OF HYPERPHOSPHATEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE NOT ON DIALYSIS IN CHINA

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xueqing Yu
Keyword(s):  
Chronic Kidney Disease ◽  
Placebo Group ◽  
Kidney Disease ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Sevelamer Carbonate ◽  
The Mean

Abstract Background and Aims Hyperphosphatemia in chronic kidney disease (CKD) patients is associated with adverse outcomes, including vascular calcification, increasing risks of disease progression and even death. Sevelamer carbonate have been approved in Europe for phosphate lowering treatment in pre-dialysis CKD patient, its efficacy and safety in Chinese CKD hyperphosphatemia patients are not previously reported. Method This was a phase III, multi-center, randomized, double blind, placebo-controlled, balanced (1:1, sevelamer: placebo) parallel-group study to evaluate the efficacy and safety of sevelamer carbonate versus placebo over 8 weeks’ duration in hyperphosphatemic CKD patients not on dialysis in China (Registration number NCT03001011). The primary objective of this study is to demonstrate efficacy of sevelamer carbonate tablets in the reduction of serum phosphorus in hyperphosphatemia in patients with chronic kidney disease (CKD) not on dialysis. Results In all, 202 patients were randomized (sevelamer, n=101; placebo, n=101); mean age was 50.7 years, 53.5% were male and the mean time of CKD diagnosis was 3.4 years with mean eGFR 7.5 ml/min/1.73 m2. The baseline phosphorous were 2.13±0.35 mmol/L and 2.12±0.37 mmol/L in sevelamer and placebo group, respectively. The mean serum phosphorous decreased significantly in patients treated with sevelamer carbonate (-0.22±0.47 mmol/L) compared with placebo (0.05±0.44 mmol/L) (mean difference between sevelamer carbonate and placebo was -0.26 mmol/L, P&lt;0.0001). When compared with placebo, sevelamer carbonate significantly reduced serum total cholesterol (-0.90±0.85 vs. -0.06±0.68 mmol/L, P&lt;0.0001), low-density lipoprotein cholesterol (-0.94±0.72 vs. -0.04±0.58 mmol/L, P&lt;0.0001) and calcium-phosphorous product (-0.48±0.97 vs. 0.05±0.81 mmol2/L2) from baseline to week 8. Serum iPTH was not significantly changed in sevelamer carbonate group compared with placebo group (-9.60±136.00 vs. 7.61±141.92 ng/L, P=0.83). Sevelamer carbonate was well tolerated with 83.27% compliance compared with 82.19% compliance in placebo arm. Average dose of sevelamer carbonate was 7.51 g/d at the end of study and 4.52 g/d across the study. Adverse events experienced by patients in sevelamer carbonate and placebo group were similar. Conclusion This study demonstrated that sevelamer carbonate has produced a significant reduction of serum phosphorous, and is safe and tolerated in Chinese pre-dialysis CKD patients with hyperphosphatemia.

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