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Clinical trial to investigate the effect of different doses of BI 685509 on renal function in people with non-diabetic chronic kidney disease
THE OBJECTIVE OF THIS TRIAL IS TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PK AND FD OF THREE ORAL DOSES OF BI 685509 FOR 20 WEEKS IN MALE AND FEMALE PATIENTS WITH NON-DIABETIC NEPHROPATHY (NND), AS ADJUNCTIVE THERAPY TO ACEI OR ARB THERAPY PLUS REFERENCE THERAPY ACCORDING TO THE RESPECTIVE GUIDELINES. THE RESULTS OF THIS TRIAL WILL BE CRUCIAL IN DECIDING WHETHER BI 685509 SHOULD BE FURTHER INVESTIGATED AND WILL SUPPORT DOSE SELECTION FOR FUTURE TRIALS.
Technical Summary
- RANDOMIZED, DOUBLE-BLIND (WITHIN DOSE GROUPS), PLACEBO-CONTROLLED, PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFECTS OF DIFFERENT DOSES OF BI 685509 ADMINISTERED ORALLY FOR 20 WEEKS ON THE REDUCTION OF URINE ALBUMIN/CREATININE RATIO (UACR) IN PATIENTS WITH NON-DIABETIC NEPHROPATHY
- Code EudraCT: 2020-002930-33
- Protocol number: 1366-0022
- Promoter: Boehringer Ingelheim España, S.A.
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