Aldosterone synthase inhibitor ( BI 690517) therapy for people with diabetes and albuminuric chronic kidney disease: A multicentre, randomized, double‐blind, placebo‐controlled, Phase I trial
Authors' conclusion
BI 690517 was generally well tolerated, reduced plasma aldosterone and may decrease albuminuria in participants with diabetes and albuminuric chronic kidney disease.
Study context
- Population
- People with diabetes and albuminuric CKD (eGFR ≥20 and <75 ml/min/1.73 m²; Urine albumin/creatinine ratio (UACR) ≥200 and <3500 mg/g), 40 sites across Europerandomized 6:1
- Participants
- 58 people
- Comparison
- BI 690517 3, 10 or 40 mg vs eplerenone vs placebo
- BI 690517 3 mgn = 18
- BI 690517 10 mgn = 13
- BI 690517 40 mgn = 14
- Eplerenonen = 4
- Placebon = 9reference
- Primary endpoint
- Proportion of participants with drug-related AEs
- Follow-up
- 28 days
Methodological detailsmulticentre, double-blind, placebo-controlled, Phase I, Randomized and treated from 27 November 2017 to 16 April 2020
- Multicentre
- Double-blind
- Placebo-controlled
- Phase I
- Randomized and treated from 27 November 2017 to 16 April 2020
Primary result
As reported in the abstract
Drug-related AEs
BI 690517 3 mg
2
events
BI 690517 10 mg
4
events
BI 690517 40 mg
2
events
- Participants with drug-related adverse events (AEs), overall
- 8 (13.8%)
Secondary outcomes
UACR response (≥20% decrease from baseline, first morning void urine) · 28 days
- UACR response (≥20% decrease from baseline, first morning void urine): 40 mg: eight of 10; placebo: three of eight
Aldosterone levels
- Aldosterone suppressed by BI 690517, but not eplerenone or placebo
Safety
| Outcome | Values |
|---|---|
| Drug-related constipation | BI 690517 10 mg 1 events · BI 690517 40 mg 1 events |
| Drug-related hyperkalaemia | BI 690517 3 mg 1 events · BI 690517 10 mg 1 events |
AE severity
- Severe hyperkalaemia (BI 690517 10 mg), serum potassium 6.9 mmol/L
- 1 participant
- Most AEs mild to moderate
Original publication
Aldosterone synthase inhibitor ( BI 690517) therapy for people with diabetes and albuminuric chronic kidney disease: A multicentre, randomized, double‐blind, placebo‐controlled, Phase I trial. Diabetes Obes Metab. Published 18 March 2024. doi:10.
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