Evaluation of RLY5016 Titration in Heart Failure Patients With Chronic Kidney Disease
The purpose of this study is to evaluate the feasibility of individualized titration of RLY5016 according to serum potassium. This study will also assess the safety and tolerability of RLY5016 and the effects of RLY5016 on serum potassium in heart failure patients with chronic kidney disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for RLY5016 in Heart Failure Patients With Chronic Kidney Disease|
- Proportion of patients with serum potassium in the normal range of 3.5 - 5.5 mEq/L at the end of the study [ Time Frame: 64 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Drug: RLY5016 + Spironolactone
Active investigational drug
This is an open-label, single-arm study to evaluate a titration regimen for RLY5016 in approximately 60 heart failure patients with chronic kidney disease receiving one or more of the following: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), or beta blockers (BBs). This study is considered to be exploratory.
Upon successful completion of screening evaluations (-10 to -5 days prior to enrollment) all eligible patients will be assigned at Baseline (Day 0 visit) to an initial dose of RLY5016 (20 g/day) and spironolactone (25 mg/day).
Study visits for enrolled patients will be scheduled for Days 3, 7, 14, 21, 28, 35, 42, 49, and 56. A follow-up visit will occur on Day 63.
At selected study visits RLY5016 or spironolactone doses may be titrated. The study dosing algorithm is designed to maintain an individual's serum potassium value in the range of 4.0 - 5.1 mEq/L (based on local lab data).
Any patient with a local lab serum potassium value < 3.5 or > 5.5 mEq/L on two consecutive scheduled study visits, despite titration of RLY5016 or spironolactone, must be withdrawn from the study, permanently discontinue RLY5016 and spironolactone, and return for a follow-up visit in 7 days.
|JSC National Center of Therapy|
|EOPL Tbilisi State Medical University|
|Emergency Cardiology Center by Academician G.Chapidze LTD|
|Diagnostic Services Clinic, LTD|
|Multiprofile Clinical Hospital of Tbilisi #2, LTD|
|Cardiology Clinic LTD|
|The Clinic of Angiocardiology "ADAPTI" LTD|
|Medical Center "CITO" LTD|
|General Hospital Celje|
|The University Clinic of Pulmonary and Allergic Diseases Golnik|
|General Hospital Izola|
|University Medical Center Ljubljana|
|University Medical Center|
|General Hospital Slovenj Gradec|
|Slovenj Gradec, Slovenia|
|Study Director:||I-Zu Huang, MD||Relypsa, Inc.|