Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension

The Lancet ◽  
2019 ◽  
Vol 394 (10196) ◽  
pp. 396-406 ◽  
Author(s):  
Donald E Wesson ◽  
Vandana Mathur ◽  
Navdeep Tangri ◽  
Yuri Stasiv ◽  
Dawn Parsell ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Metabolic Acidosis ◽  
Kidney Disease ◽  
Safety And Efficacy

scholarly journals Safety and Efficacy of Long-Term Use of Tolvaptan in Patients With Heart Failure and Chronic Kidney Disease

2017 ◽  
Vol 81 (11) ◽  
pp. 1736-1738 ◽  
Author(s):  
Yusuke Uemura ◽  
Rei Shibata ◽  
Kenji Takemoto ◽  
Tomohiro Uchikawa ◽  
Masayoshi Koyasu ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Safety And Efficacy ◽  
Patients With Heart Failure

scholarly journals Denosumab Safety and Efficacy Among Participants in the FREEDOM Extension Study With Mild to Moderate Chronic Kidney Disease

2020 ◽  
Author(s):  
Aaron Broadwell ◽  
Arkadi Chines ◽  
Peter R Ebeling ◽  
Edward Franek ◽  
Shuang Huang ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Mineral Density ◽  
Pivotal Phase ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Ckd Stage ◽  
Moderate Chronic Kidney Disease ◽  
To Receive

Abstract Context The effects of long-term exposure to denosumab in individuals with renal insufficiency are unknown. Objective This post hoc analysis evaluates the long-term safety and efficacy of denosumab in individuals with mild-to-moderate chronic kidney disease (CKD) (stages 2 and 3) using data from the pivotal phase 3, double-blind, 3-year FREEDOM (NCT00089791) and open-label, 7-year extension (NCT00523341) studies. Participants and Methods Women age 60 to 90 years with a bone mineral density (BMD) T-score of less than –2.5 to greater than –4.0 at the total hip or lumbar spine were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months (long-term arm) or placebo (cross-over arm) in FREEDOM; eligible participants could enroll in the extension to receive denosumab 60 mg subcutaneously every 6 months. Change in estimated glomerular filtration rate (eGFR) from study baseline and annualized rates of fracture and adverse events (AEs) were the main outcome measures. Results Most participants (1259/1969 [64%] long-term arm; 1173/1781 [66%] crossover arm) with baseline CKD stage 2 or 3 remained within the same CKD subgroup at study completion; less than 3% progressed to CKD stage 4. Participants in all eGFR subgroups showed similar, persistent BMD gains over time and a low incidence of fractures. The percentage of participants reporting serious AEs was similar among renal subgroups (normal, CKD stage 2, CKD stage 3a, CKD stage 3b) both for the long-term (54% vs 52% vs 57% vs 58%) and crossover (43% vs 42% vs 43% vs 68%) arms, except CKD stage 3b subgroup, crossover arm. Conclusion The safety and efficacy of denosumab did not differ among participants with mild to moderate CKD.

scholarly journals Long-term Safety and Efficacy of Difelikefalin in Subjects With Chronic Kidney Disease–Associated Pruritus: Analysis From KALM-1 and KALM-2

2021 ◽  
Vol 5 (6) ◽  
pp. s75
Author(s):  
Steve Fishbane ◽  
Warren Wen ◽  
Catherine Munera ◽  
Frédérique Menzaghi ◽  
Kieran McCafferty
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Safety And Efficacy

N/A

Long-Term Safety and Efficacy of Bixalomer in Hyperphosphatemic Patients With Chronic Kidney Disease Not on Dialysis

2017 ◽  
Vol 21 (2) ◽  
pp. 173-179 ◽  
Author(s):  
Tadao Akizawa ◽  
Junko Tsukada ◽  
Chisato Kameoka ◽  
Kentarou Kuroishi ◽  
Yusuke Yamaguchi
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Safety And Efficacy

scholarly journals Efficacy and Safety of Veverimer in the Treatment of Metabolic Acidosis Caused by Chronic Kidney Disease: A Meta-analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Wenlin Liu ◽  
Lili Li ◽  
Xuemei Zhang ◽  
Haonan Dong ◽  
Miaomiao Lu
Keyword(s):  
Chronic Kidney Disease ◽  
Metabolic Acidosis ◽  
Kidney Disease ◽  
Short Form ◽  
Meta Analysis ◽  
High Capacity ◽  
Current Evidence ◽  
Efficacy And Safety

Metabolic acidosis is a common complication of chronic kidney disease (CKD). Veverimer is an orally administrated, free amine polymer with high capacity and binding selectivity to hydrochloric acid from the gastrointestinal tract. This study pooled the current evidence of the efficacy and safety of veverimer for the treatment of metabolic acidosis associated with CKD. We conducted a systematic literature search on PubMed, Embase, and Cochrane Central for relevant randomized controlled trials (RCTs) in June 2020. In this study, three RCTs with 548 patients were included in our analysis. The analysis revealed that veverimer was associated with increased bicarbonate level of patients (weight mean difference [WMD] 3.08, 95% confidence interval [CI] [2.40, 3.77], p < 0.001) and improved physical function compared with placebo measured by Kidney Disease and Quality of Life Short Form 36, question 3 (physical functioning domain) (KDQoL-PFD) score (WMD 5.25, 95% CI [1.58, 8.92], p = 0.005). For safety outcomes, both groups exhibited similar risks for developing headache, diarrhea, flatulence, and hyperkalemia. In conclusion, current clinical evidence indicates that veverimer is efficacious and safe against metabolic acidosis related to CKD compared with placebo. Further research comparing long-term veverimer use with traditional alkali therapy is needed.

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