Trial summary

Boehringer Ingelheim Phase II Trial 1366-0005

Document name – description

Document name – description

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 diabetic kidney disease.


Trial objective
The main objectives of the trial are to demonstrate the effectiveness of BI 685509 and to characterize the dose-response relationship for BI 685509 in patients with Diabetic Kidney Disease by assessing 3 doses and placebo. BI 685509 will 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.

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


Main in- and exclusion criteria
Inclusion:
– 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
– Stable treatment with either ACEi or ARB (not both)
– Patients with stable type 1 or type 2 diabetes mellitus

Exclusion:
– Non-diabetic chronic 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), I would appreciate if you would let me know so that the patient’s continuing participation in the trial can be assessed.


Trial contact details
Elif Ekinci   
Phone 03 9496 2250    Email elif.ekinci@unimelb.edu.au