Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Relypsa, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
