Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease

Phase 2

Completed

• Conditions: Hyperkalemia; Resistant Hypertension
• Interventions: Drug: Placebo; Drug: Patiromer; Drug: Spironolactone

• Registration Number: NCT03071263
• Lead Sponsor: Relypsa, Inc.

Brief Summary

The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).

Detailed Description

Approximately 290 eligible participants with \[chronic kidney disease (CKD) on stable doses of medication\] will be randomly assigned to receive a patiromer or placebo starting dose of two packets a day, once a day.

All eligible participants will undergo a screening/run-in period (up to 4 weeks) to determine eligibility for study entry. Eligible participants will be randomized and treated for 12 weeks (Treatment Period) and followed for 2 weeks after completing the patiromer or placebo treatment. There are 8 planned clinic visits during the Treatment Period and one planned visit two weeks after the last dose of patiromer or placebo (Follow-up Period).

The dose of patiromer or placebo may be increased or decreased (titrated) based on participants' individual potassium response.

Study Timeline

• Study Start: 2017-01-23
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-06
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Results First Submitted: 2019-11-27
• Results First Submitted QC: 2020-01-13
• Results First Posted: 2020-01-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

• Age ≥ 18 years
• Taking at least three medications for blood pressure (one a diuretic)
• Uncontrolled high blood pressure
• Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45 mL/min/1.73m2
• Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)

Exclusion Criteria

• History of untreated known causes of high blood pressure, excluding kidney disease (not CKD)
• Inability to measure BP
• Not taking high blood pressure medications as prescribed medications
• Recent change in renal function (in the past 3 months) which has required hospitalization or dialysis
• Renal transplant
• History of cancer within past 12 months
• Recent cardiovascular event with last 3 months
• Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial fibrillation with uncontrolled heart rate)
• Inability to take study medication
• Alcoholism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Placebo	Placebo	spironolactone + blinded placebo
Group 2 - Placebo	Spironolactone	spironolactone + blinded placebo
Group 1 - Patiromer	Patiromer	spironolactone + blinded patiromer
Group 1 - Patiromer	Spironolactone	spironolactone + blinded patiromer

Primary Outcome Measures

Name	Time	Method
Number of Participants Remaining on Spironolactone at Week 12	At week 12	The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12.

Secondary Outcome Measures

Name	Time	Method
Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications	From baseline to Week 12	AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure

Trial Locations

Locations (40)

Investigator Site 1402; 🇧🇬 Sofia, Bulgaria

Investigator Site 1022; 🇺🇸 Chicago, Illinois, United States

Investigator Site 1023; 🇺🇸 Miami Lakes, Florida, United States

Investiagor Site 2205; 🇭🇷 Zagreb, Croatia

Investigator Site 3807; 🇬🇪 Tbilisi, Georgia

Investigator Site 2203; 🇭🇷 Zagreb, Croatia

Investigator Site 8202; 🇬🇧 Leicester, United Kingdom

Investigator Site 8205; 🇬🇧 London, United Kingdom

Investigator Site 1012; 🇺🇸 Hollywood, Florida, United States

Investigator Site 2201; 🇭🇷 Zagreb, Croatia

Investigator Site 3806; 🇬🇪 Tbilisi, Georgia

Investigator Site 3802; 🇬🇪 Tbilisi, Georgia

Investigator Site 3811; 🇬🇪 Tbilisi, Georgia

Investigator Site 3812; 🇬🇪 Tbilisi, Georgia

Investigator Site 3805; 🇬🇪 Tbilisi, Georgia

Investigator Site 3810; 🇬🇪 Tbilisi, Georgia

Investigator Site 3801; 🇬🇪 Tbilisi, Georgia

Investigator Site 3813; 🇬🇪 Tbilisi, Georgia

Investigator Site 3804; 🇬🇪 Tbilisi, Georgia

Investigator Site 3808; 🇬🇪 Tbilisi, Georgia

Investigator Site 3809; 🇬🇪 Tbilisi, Georgia

Investigator Site 4607; 🇭🇺 Balatonfured, Hungary

Investigator Site 7805; 🇺🇦 Kiev, Ukraine

Investigator Site 4202; 🇩🇪 Gottingen, Germany

Investigator Site 4601; 🇭🇺 Hatvan, Hungary

Investigator Site 4606; 🇭🇺 Budapest, Hungary

Investigator Site 4611; 🇭🇺 Debrecen, Hungary

Investigator Site 4602; 🇭🇺 Miskolc, Hungary

Investigator Site 7403; 🇿🇦 Johannesburg, South Africa

Investigator Site 7803; 🇺🇦 Khar'kov, Ukraine

Investiagor Site 7809; 🇺🇦 Kharkiv, Ukraine

Investigator Site 4610; 🇭🇺 Miskolc, Hungary

Investigator Site 4608; 🇭🇺 Mosonmagyarovar, Hungary

Investigator Site 7801; 🇺🇦 Kiev, Ukraine

Investigator Site 7802; 🇺🇦 Kharkiv, Ukraine

Investigator Site 7804; 🇺🇦 Zaporizhzhia, Ukraine

Investigator Site 7807; 🇺🇦 Zaporizhzhia, Ukraine

Investigator Site 4605; 🇭🇺 Kistarcsa, Hungary

Investigator Site 2202; 🇭🇷 Zagreb, Croatia

Investigator Site 7808; 🇺🇦 Kharkiv, Ukraine