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Current Studies

BI Trial No. 1378-0005

A study to test whether different doses of BI 690517 alone or in combination with empagliflozin improve kidney function in people with chronic kidney disease

Status: Enrolling

Type of Study: Randomized, double-blind, placebo-controlled therapy

Study Length: 14 weeks

Target Age/Sex: Over 18 years, Male and Female

Benefits:
Participants will receive at no cost: study medication and study related supplies, study related lab work and study related exams.

Link: https://clinicaltrials.gov/ct2/show/NCT03165240

Description:
Randomized, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease

ANJ900D3501

A randomized, multicenter, double-blind, parallel-group, placebo- and comparator-controlled study to compare the glycemic effects, safety, and tolerability of Metformin hydrochloride delayed-release tablets in patients with type 2 Diabetes Mellitus with varying renal function from normal up to CKD3b

Status: Enrolling

Type of Study: Randomized, double-blind, placebo-controlled therapy

Study Length: 14 weeks

Target Age/Sex: Over 18 years, Male and Female

Benefits:

Participants will receive at no cost: study medication and study related supplies, study related lab work and study related exams.

Link: https://clinicaltrials.gov/ct2/show/NCT03165240

Description:
Randomized, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease

STABILIZE-CKD

Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants with CKD and Hyperkalemia or at Risk of Hyperkalemia

Status: Enrolling

Type of Study:  A Phase 3, International, Randomized, Double-Blind,

Placebo Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Patients with CKD and Hyperkalemia or at Risk of Hyperkalemia 

Study Length: 28 months

Target Age/Sex: Over 18 years, Male and Female

Benefits:
Participants will receive at no cost: study medication and study related supplies, study related lab work and study related exams.

Link: https://clinicaltrials.gov/ct2/show/NCT05056727

Description:
This is a Phase 3, international, randomized withdrawal, double-blind, parallel-group, placebo-controlled study, to evaluate the effect of SZC as adjunct to RAASi therapy (lisinopril or valsartan) in slowing CKD progression in participants with CKD and hyperkalemia or at risk of hyperkalemia.

Specifically, the study will include participants with hyperkalemia (S-K > 5.0 to ≤ 6.5 mmol/L by central laboratory) who are on adequate or limited RAASi therapy due to hyperkalemia, and participants with normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L by central laboratory) who are on limited RAASi therapy due to high risk of hyperkalemia. High risk of hyperkalemia is defined as (1) participants with a previous medical history or record of hyperkalemia within the prior 24 months who are on limited RAASi therapy despite indication in CKD; (2) participants in whom RAASi therapy is indicated in CKD but are on limited RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L; and (3) participants in whom RAASi therapy has been discontinued or reduced to suboptimal doses because of hyperkalemia.