Hyperkalemia MedDRA version: 14.1 Level: LLT Classification code 10020647 Term: Hyperkalemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Patiromer
Product Code: RLY5016
Pharmaceutical Form: Powder for oral suspension
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Ora
Sponsors
Relypsa Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must have CKD and be on any dose of at least one RAAS inhibitor medication at Screening. Subjects must also have pre-existing hyperkalemia. Part A - Inclusion Criteria: Subjects in Part A must meet ALL the following criteria: 1.Age 18 – 80 years old at screening. 2.Chronic kidney disease: eGFR 15 to =65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: Part A - Exclusion Criteria Subjects in Part A must NOT meet ANY of the following exclusion criteria: 1.Subjects with any level of hyperkalemia at screening that, in the opinion of the investigator, requires emergency intervention. 2.Any subject with potassium-related ECG changes at Screening. 3.Subjects with auto-immune related chronic kidney disease such as lupus nephritis, renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement. 4.Type 1 diabetes or a hemoglobin A1c (HbA1c) measurement of > 10.0% within the previous 6 months in subjects with type 2 diabetes (T2DM). 5.Hospitalization (either in-patient or emergency room treatment) for hyper- or hypoglycemia in subjects with T2DM or for acute exacerbations of heart failure (HF) within the last 3 months. 6.A history of, or currently diagnosed diabetic gastroparesis or history of bariatric surgery 7.A confirmed SBP = 180 mm Hg or 3 times upper limit of normal at screening, based on the local lab ALT and AST results. 19.Active cancer, currently on cancer treatment or history of cancer in the past two years except for non-melanocytic skin cancer that is considered cured. 20.History of alcoholism or drug/chemical abuse within 1 year of screening. 21.Use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to screening. 22.Any of the potassium-altering chronic medications that are stated in the protocol if doses have not been stable for at least 28 days prior to screening or if doses are anticipated to change during study participation 23.Use of the drugs stated in the protocol. 24.Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening. 25.Prior participation (excluding screen or enrollment failures) in any study assessing the efficacy and safety of patiromer. 26.Inability to consume the investigational product or, in the opinion of the Investigator, inability to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: To evaluate the efficacy and safety of patiromer for the treatment of hyperkalemia. Part B: To evaluate the effect of withdrawing patiromer on serum potassium control; To assess whether chronic treatment with patiromer prevents the recurrence of hyperkalemia To provide placebo-controlled safety data.;Secondary Objective: n/a;Primary end point(s): Part A: Change in serum potassium Part B: Change in serum potassium;Timepoint(s) of evaluation of this end point: Part A: Part A baseline to Part A Week 4 Part B: Part B Week 4, without any modification to either renin angiotensin aldosterone system (RAAS) inhibition therapy or investigational drug (patiromer); or At an earlier time point when either the RAAS inhibition therapy or the dose of investigational drug (patiromer) needs to be adjusted to manage a serum potassium (K+) < 3.8 mEq/L or = 5.5 mEq/L. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Part A: Week 4 Part B: at any time through Week 8 Part B: at any time through Week 8 ;Secondary end point(s): Part A: having Serum K+ level in the target range of 3.8 to <5.1 mEq/L and Part B: Having K+ more than or equal to 5.1 mEq/L at any time through Week 8 Part B: Having K+ more than or equal to 5.5 mEq/L at any time through Week 8 | — |
Countries
Bulgaria, Croatia, Czech Republic, Denmark, Georgia, Hungary, Italy, Russian Federation, Serbia, Slovenia, Spain, Ukraine, United States
Contacts
Public ContactNancy Newark
Worldwide Clinical Trials Ltd
Outcome results
None listed