MIRO-CKD
Research type
Research Study
Full title
A Phase IIb, Multicentre, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination with Dapagliflozin Compared with Dapagliflozin in Patients with Chronic Kidney Disease and Albuminuria
IRAS ID
1009753
Contact name
Arbab Bhatti
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2023-509709-63
Research summary
This is a clinical trial funded by AstraZeneca to assess the efficacy (whether it works) and safety of an investigational drug called balcinrenone/dapaglifozin (which is a combination of two drugs) for the treatment of chronic kidney disease (CKD) in patients who have elevated levels of a protein called albumin in the urine. Despite current standard therapy for CKD, some people continue to experience decline in kidney function and for this reason, new medicines need to be developed.
Participants in this study will be over 18 years of age and have CKD with elevated levels of albumin in the urine. Suitable participants will be randomly assigned to either balcinrenone 15mg/dapaglifozin 10mg, balcinrenone 40mg/dapaglifozin 10mg or dapaglifozin 10mg alone (dapaglifozin is a standard therapy for CKD). Neither participants nor the study staff assessing them will know whether patient have received balcinrenone/dapaglifozin or dapaglifozin alone. It is not certain that participants will directly benefit from the combination therapy beyond standard treatment. If the balcinrenone/dapaglifozin combination works, the future benefit from the medication will prevent worsening of kidney disease over time.
The study will last at least 23 weeks across three stages, including screening (to assess eligibility for the study), treatment (12 weeks) and follow-up (8 weeks). There will be at least 8 visits conducted in the UK and other countries. The study will be conducted at commercial research sites, hospitals, and GP/specialist clinics.
During the study, participants will undergo various tests, including blood and urine tests, heart tracings (ECGs), physical exams and will be asked about their medications and any medical problems.
The possible risks for taking balcinrenone with dapagliflozin include high levels of potassium, temporary decline of your kidney function, low blood pressure and diabetic ketoacidosis (in participants with diabetes).REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0236
Date of REC Opinion
2 May 2024
REC opinion
Further Information Favourable Opinion