Hyperkalemia in Patients with Hypertension and Diabetic Nephropathy MedDRA version: 13.1 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 13.1 Level: LLT Classification code 10020647 Term: Hyperkalemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: RLY5016 powder for suspension
Product Code: RLY5016
Pharmaceutical Form: Powder for oral suspension
CAS Number: 1208912-84-8
Current Sponsor code: RLY5016S
Concentration unit: g gram(s)
Sponsors
Relypsa, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet ALL of the following inclusion criteria: 1. Age 30 – 80 years old at screening 2. Type 2 diabetes mellitus (T2DM) diagnosed after age 30 which has been treated with oral medications or insulin for at least one year prior to screening 3. Chronic kidney disease (estimated GFR 15 – 5.0 – =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Patients must NOT meet ANY of the following exclusion criteria: 1. Type 1 diabetes mellitus 2. Hemoglobin A1c > 12% at screening or emergency treatment for T2DM within the last 3 months 3. Diabetic gastroparesis 4. Non-diabetic chronic kidney disease 5. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., cholectomy) 6. Current diagnosis of NYHA Class III or IV heart failure 7. Body mass index (BMI) = 40 kg/m2 8. Any of the following events having occurred within 2 months prior to screening: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, cardiac arrest or clinically significant ventricular arrhythmias, transient ischemic attack or stroke, use of any intravenous cardiac medication 9. Prior kidney transplant, or anticipated need for transplant during study participation 10. Active cancer, currently on cancer treatment or history of cancer in the past two years except for nonmelanocytic skin cancer which is considered cured 11. History of alcoholism or drug/chemical abuse within 1 year 12. Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal 13. Loop and thiazide diuretics or other antihypertensive medications (calcium channel blocker, beta-blocker, alpha-blocker, or centrally acting agent) that have not been stable for at least 28 days prior to screening or not anticipated to remain stable during study participation 14. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol, cholestyramine), phosphate binders (e.g., lanthanum carbonate), or other potassium binders, or their anticipated need during study participation 15. Current use of lithium 16. Use of potassium sparing medications, including aldosterone antagonists (e.g., spironolactone), potassium supplements, bicarbonate or baking soda in the last 7 days prior to screening 17. Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening 18. Patients who have taken RLY5016 previously 19. Inability to consume the investigational product, or, in the opinion of the Investigator, inability to comply with the protocol 20. In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardize the safety of the patient or affect the validity of the trial results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the optimal starting dose of RLY5016 in treating hyperkalemia in patients with hypertension and diabetic nephropathy receiving ACEI and/or ARB drugs, with or without spironolactone;Secondary Objective: The secondary objectives of this study are: •To determine the efficacy of RLY5016 in treating hyperkalemia in patients with hypertension and diabetic nephropathy receiving ACEI and/or ARB drugs, with or without spironolactone •To determine the safety of RLY5016 in treating hyperkalemia in patients with hypertension and diabetic nephropathy receiving ACEI and/or ARB drugs, with or without spironolactone;Primary end point(s): Mean change in serum potassium from baseline to week 4 or prior to the initiation of RLY5016 dose titration (if occurs before week 4);Timepoint(s) of evaluation of this end point: Week 4 or earlier if RLY5016 dose titration is initiated before Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Mean change in serum potassium from baseline to week 8 or prior to the initiation of RLY5016 dose titration 2. Proportion of patients maintaining the starting RLY5016 dose at week 4 and 8 3. Mean change in serum potassium from baseline to post-baseline visits 4. Proportion of patients requiring RLY5016 titration 5. Mean time to first RLY5016 titration 6. Mean number of RLY5016 titrations 7. Proportion of patients who maintain serum potassium (K+) in the range of 3.5 – 5.5 mEq/L by visit and during the entire study treatment period 8. Proportion of patients who maintain serum K+ in the range of 4.0 – 5.0 mEq/L by visit and during the entire study treatment period 9. Proportion of patients who discontinue from the study due to high serum potassium withdrawal criteria 10. Mean change in blood pressure from screening to week 4 and 8 11. Mean change in urine albumin to creatinine ratio (ACR) from screening to week 4 and 8 12. Proportion of patients with = 35% reduction in urine ACR from screening to week 4 and 8 13. Proportion of patients with urine ACR = 500 mg/g at screening who achieve ACR < 500 mg/g at week 4 and 8 ;Timepoint(s) of evaluation of this end point: 1. Week 8 or earlier if RLY5016 titration is initiated before Week 8 2. Weeks 4 and 8 3. Weeks 1-8 and 7 days following final treatment visit 4. Through Week 8 5. Through Week 8 6. Week 8 7. Weeks 1-8 8. Weeks 1-8 9. Through Week 8 10. Weeks 4 and 8 11. Weeks 4 and 8 12. Weeks 4 and 8 13. Weeks 4 and 8 | — |
Countries
Austria, Croatia, Georgia, Germany, Hungary, Serbia, Slovenia
Contacts
Public ContactKaren Hill
Worldwide Clinical Trials Ltd.
Outcome results
None listed