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Completed

NCT Number: NCT03071263

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

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).

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Key information

Conditions

Hyperkalemia Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Resistant Hypertension Urogenital Diseases Urologic Diseases Vascular Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator Site 1402, Sofia, Bulgaria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patiromer

Drug

2 packets/day starting dose, administered orally

Other names: Veltassa, RLY5016 for Oral Suspension, Patiromer for Oral Suspension

Placebo

Drug

2 packets/day starting dose, administered orally

Spironolactone

Drug

25 mg tablet/day starting dose, administered orally

Primary outcomes

  1. Number of Participants Remaining on Spironolactone at Week 12

    Time frame: 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 outcomes

  1. 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

    Time frame: From baseline to Week 12

    AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure

Other outcomes

  1. Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives

    Time frame: From baseline to Week 12

    AOBP SBP: Automated Office Systolic Blood Pressure

  2. Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category

    Time frame: From baseline to Week 12

    The two baseline potassium subgroups, 4.3-<4.7 mEq/L versus 4.7-5.1 mEq/L, are based on central laboratory data.

    If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP <4.3 mEq/L or >5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period.

  3. Participants With Central Serum Potassium <5.5 mEq/L Over Time

    Time frame: From baseline to Week 12

    Baseline Central Serum Potassium: BCSP.

    The symbols > and ≤ included in the row titles are used to indicate the time interval [">Week1 and ≤Week2" meaning from day 8 until day 14 (included)].

    If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP <4.3 mEq/L or >5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period.

  4. Participants Having Spironolactone Titrations Over Time

    Time frame: From baseline to Week 12

    The titration was performed according to the following criteria: Spironolactone was increased in cases of hypertension, decreased or stopped in cases of hypotension and maintained if the blood pressure results were adequate

    The symbols > and ≤ included in the row titles are used to indicate the time interval [">Week1 and ≤Week2" meaning from day 8 until day 14 (included)].

  5. Number of Participants by Spironolactone Dose Prescribed at Each Visit

    Time frame: From baseline to Week 10

    QD: Once daily

    QOD: Once every other day

  6. Shifts in Selected Laboratory Tests From Baseline to End of Treatment

    Time frame: From Baseline to End of Treatment, up to 12 weeks.

    The end of treatment value is defined as the last non-missing value on or prior to the last spironolactone dose date (from End of Treatment - Case report form) + 3 days

    LLN=Lower limit of the normal range. ULN=Upper limit of the normal range. EoT=End of Treatment

  7. Spironolactone Dose Level at End of 12 Weeks of Study Treatment

    Time frame: 12 Weeks of Study Treatment

    Row title:

    Participants not completing 12W of study treatment: Participants who had not completed 12 weeks of study treatment.

Sponsors and collaborators

Lead sponsor

Relypsa, Inc.

Industry

Registry information

Official study 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

Acronym: AMBER

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2017
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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