PACIFIC
Research type
Research Study
Full title
A Phase III, Randomised, Double-blind, Placebo-controlled, Eventdriven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants with Chronic Kidney Disease and High Blood Pressure
IRAS ID
1011084
Contact name
Adilah Hussain
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat chronic kidney disease (CKD) and high blood pressure. The kidneys help the body control and remove fluid and get rid of unnecessary substances in the urine. In people with CKD, kidney function slowly worsens over time. This can lead to symptoms such as tiredness, shortness of breath, nausea, swollen limbs, and confusion. High blood pressure is common in people with CKD. This can lead to increased risk of heart disease and kidney failure. Here a person’s kidneys can no longer remove enough of the extra fluid and unnecessary substances resulting in need for dialysis treatment (acts like an artificial kidney), or a kidney transplant. In this trial, researchers are looking into how well a drug called baxdrostat works and how safe it is when combined with another drug called dapagliflozin. Dapagliflozin is a type of medication that is already approved to help people with CKD. It helps the body remove sugar from the blood through the urine and helps to slow the worsening of kidney function in CKD. However, dapagliflozin cannot completely prevent the worsening of CKD. Baxdrostat is made to stop extra fluid and waste from building up in the body and to reduce high blood pressure. Researchers want to learn if taking baxdrostat with dapagliflozin could help participants with CKD and high blood pressure more than taking dapagliflozin with a placebo. The placebo will look like baxdrostat but will not have any medicine in it. This trial will include up to about 5,000 participants. To join people must be 18 years of age or older and have CKD with high blood pressure. Participants already taking a drug for their CKD similar to dapagliflozin will be randomly put in either treatment or placebo arm while also receiving dapagliflozin. Participants who are not already taking dapagliflozin will begin the trial by taking 10 milligrams (mg) of dapagliflozin every day for 4 weeks before being randomised in primary or secondary care sites.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0001
Date of REC Opinion
5 Feb 2025
REC opinion
Further Information Favourable Opinion