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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperkalemia, Resistant Hypertension

In brief

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).

Key facts

Study ID

NCT03071263

Run by

Relypsa, Inc.

People needed

295

Starts

2017-01-23

Expected to finish

2018-11-27

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Investigator Site 1012 — Hollywood, Florida, United States
• Investigator Site 1023 — Miami Lakes, Florida, United States
• Investigator Site 1022 — Chicago, Illinois, United States
• Investigator Site 1402 — Sofia, Bulgaria
• Investiagor Site 2205 — Zagreb, Croatia
• Investigator Site 2201 — Zagreb, Croatia
• Investigator Site 2202 — Zagreb, Croatia
• Investigator Site 2203 — Zagreb, Croatia
• Investigator Site 3806 — Tbilisi, Georgia
• Investigator Site 3811 — Tbilisi, Georgia
• Investigator Site 3802 — Tbilisi, Georgia
• Investigator Site 3801 — Tbilisi, Georgia
• Investigator Site 3804 — Tbilisi, Georgia
• Investigator Site 3805 — Tbilisi, Georgia
• Investigator Site 3807 — Tbilisi, Georgia
• Investigator Site 3808 — Tbilisi, Georgia
• Investigator Site 3810 — Tbilisi, Georgia
• Investigator Site 3812 — Tbilisi, Georgia
• Investigator Site 3813 — Tbilisi, Georgia
• Investigator Site 3809 — Tbilisi, Georgia
• Investigator Site 4202 — Göttingen, Germany
• Investigator Site 4607 — Balatonfüred, Hungary
• Investigator Site 4606 — Budapest, Hungary
• Investigator Site 4611 — Debrecen, Hungary
• Investigator Site 4601 — Hatvan, Hungary

Full record on ClinicalTrials.gov

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