A study to test the effect of different doses of BI 685509 on kidney function in people with chronic kidney disease

Boehringer Ingelheim Phase II Trial 1366-0022

Trial description
Randomised, double-blind (within dose groups), placebo-controlled and parallel group trial to investigate the effects of different doses of oral BI 685509 given over 20 weeks on UACR reduction in patients with non-diabetic kidney disease.

Trial objective
The main objectives of the trial are to determine the effectiveness of BI 685509 and to characterize the dose-response relationship for BI 685509 in patients with non-diabetic kidney disease by assessing 3 doses and placebo. For patients with macroalbuminuria (>300 mg/g) this should be given as an adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) treatment plus local standard of care according to respective guidelines. For patients with microalbuminuria the use of ACEi/ ARB is not mandated for inclusion in the trial.

BI 685509 has not been approved as a treatment for any disease by the Therapeutic Goods Administration (TGA) so its use in this clinical study is considered experimental.

BI 685509 – The Investigational Medicinal Product
BI 685509 is an activator of soluble guanylate cyclase (sGC) leading to an increased production of cGMP. This in turn is a potent mediator of vascular relaxation and, furthermore, crucial for proper endothelial function in the vascular bed. In the long run this may improve kidney function and slow or halt progress of kidney disease.

About the Trial
Patients will be randomly assigned to receive either the BI 685509 or placebo in one of three dose groups. Patients will be receiving BI 685509 or placebo for 20 weeks. The first 6 weeks of this will be an up-titration period. Information about the study visits and the trial protocol is available in the attached Participant Information Sheet/Consent Form.

Trial inclusion criteria
Male or female patients aged ≥ 18 years at time of consent
eGFR ≥ 20 and < 90 mL/min/1.73 m²
UACR ≥ 200 and < 3,500 mg/g
In the Investigator’s judgement any kind of diagnosed chronic kidney disease whose primary cause is clinically not considered to be of diabetic origin

Trial exclusion criteria
Diagnosed with diabetic kidney disease
Planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment

Required background medication and restricted medication
If you become aware of the necessity to change the concomitant medication for this patient (or if surgery is planned), please let the trial coordinator know so that the patient’s continuing participation in the trial can be assessed.