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

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ClinicalTrials.gov Identifier: NCT03071263
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Hyperkalemia Resistant Hypertension Drug: Patiromer Drug: Placebo Drug: Spironolactone Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Group 1 - Patiromer
spironolactone + blinded patiromer
Drug: Patiromer
2 packets/day starting dose, administered orally
Other Names:
  • Veltassa
  • RLY5016 for Oral Suspension
  • Patiromer for Oral Suspension

Drug: Spironolactone
25 mg tablet/day starting dose, administered orally

Experimental: Group 2 - Placebo
spironolactone + blinded placebo
Drug: Placebo
2 packets/day starting dose, administered orally

Drug: Spironolactone
25 mg tablet/day starting dose, administered orally




Primary Outcome Measures :
  1. Treatment group difference (spironolactone plus patiromer vs. spironolactone plus placebo) in proportion of subjects remaining on spironolactone at Week 12 [ Time Frame: Week 12 ]
    The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo).


Secondary Outcome Measures :
  1. Treatment group difference in systolic blood pressure (SBP) change by automated office blood pressure (AOBP) measurements from baseline to Week 12 or last available AOBP prior to addition of any new or baseline medications or changes in BP [ Time Frame: Baseline and Week 12 ]
    The secondary efficacy variable for this study is change from Baseline in AOBP SBP at Week 12 or last available assessment prior to addition of any new BP medications or changes to any baseline BP medications.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071263


Contacts
Contact: Head of Clinical Operations 650-421-9500 Amber@relypsa.com

  Show 60 Study Locations
Sponsors and Collaborators
Relypsa, Inc.
Investigators
Study Director: Study Director or VP Clinical Development Relypsa, Inc.

Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT03071263     History of Changes
Other Study ID Numbers: RLY5016-207
2016-002657-38 ( EudraCT Number )
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Relypsa, Inc.:
Treatment of Hyperkalemia
Hyperkalemia
Potassium
Chronic Kidney Disease
Hypertension
Resistant Hypertension
Spironolactone

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Hyperkalemia
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents