Clinical Trials Logo

Clinical Trial Summary

This is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part B) and a 2-week follow-up period.


Clinical Trial Description

In Part A, participants who meet all eligibility criteria will initiate patiromer at an oral dose of 8.4 g (1 packet/day). The dose will be adjusted based on the serum potassium (sK+) levels. After the completion of part A, all the participants who meet the eligibility criteria for Part B will be randomised to receive patiromer or placebo. Participants will start Part B with the same dose of patiromer they were receiving at the end Part A. However, Patiromer dose may be up- or down-titrated based on sK+ levels. The primary objectives of the study are: Part A - To evaluate the efficacy of patiromer for the treatment of hyperkalemia in Chinese subjects. Part B - To evaluate the effect of withdrawing patiromer on sK+ control. To determine if the treatment with patiromer will result in continued use of renin-angiotensin-aldosterone system inhibitor (RAASi) medications. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05136664
Study type Interventional
Source Vifor Fresenius Medical Care Renal Pharma
Contact PAT-CHINA-303 Clinical Study Team
Phone +41 588 518 000
Email clinicaltrials@cslbehring.com
Status Recruiting
Phase Phase 3
Start date February 10, 2022
Completion date November 2026

See also
  Status Clinical Trial Phase
Terminated NCT05056727 - A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia Phase 3
Withdrawn NCT01655186 - A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus Phase 2
Completed NCT03481686 - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections N/A
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Enrolling by invitation NCT02237534 - Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia Phase 4
Completed NCT02126293 - Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant Phase 3
Terminated NCT01533545 - Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients N/A
Completed NCT03280615 - Omega 3 Fatty Acids in Patients With Chronic Renal Disease Phase 3
Completed NCT04498156 - Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)
Recruiting NCT04020328 - Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency Phase 4
Recruiting NCT06366529 - Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed NCT03836508 - Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis N/A
Completed NCT03250715 - Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure N/A
Completed NCT03577249 - Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation Phase 2/Phase 3
Completed NCT01975818 - Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 Phase 2
Active, not recruiting NCT05766644 - App-based Education Program for CKD N/A
Active, not recruiting NCT02791880 - Acute Kidney Injury Genomics and Biomarkers in TAVR Study
Recruiting NCT02947750 - Neurovascular Transduction During Exercise in Chronic Kidney Disease Phase 2
Terminated NCT02286258 - Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR) Phase 1/Phase 2