A Phase 3 interventional study of Balcinrenone/dapagliflozin and Dapagliflozin in Renal Insufficiency, Chronic, sponsored by AstraZeneca. Recruiting at 478 sites in 27 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
Among 40 studies testing dapagliflozin in Renal Insufficiency, Chronic — 15 open to participants now, 21 under way, 7 of them phase 3. dapagliflozin · Renal Insufficiency, Chronic.
Among the 40 studies testing dapagliflozin in Renal Insufficiency, Chronic, this one is the 4th largest by planned enrollment, is one of 6 that started in 2026, is one of 10 in phase 3, reaches primary completion later than 20 of the 20 other live ones, and was the 39th registered.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
Browse Renal Insufficiency, Chronic studies →15 of the 40 studies testing dapagliflozin in Renal Insufficiency, Chronic are open now, in 12 countries. Recruiting first, the newest first:
Centenario Hospital Miguel Hidalgo · Sites in Mexico
Ages 14–18
Oman Ministry of Health · Sites in Oman
Ages 13+
Peter Rossing · Sites in Denmark, Germany, Spain and 1 more country
Ages 18–75
Ain Shams University · Sites in Egypt
Ages 18+
Maximo Agustin Schiavone · Sites in Argentina
Ages 18–70
By country, each count listing its studies:
dapagliflozin: first FDA approval 2014 (FARXIGA), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 15 · Phase 3 11 · Phase 4 11
First in 2015; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 2,800 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 100 across the 40 interventional studies. Of the 18 that completed or were terminated, 3 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 40 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
50 studies in Renal Insufficiency, Chronic by AstraZeneca: 6 open now, 10 under way, 4 of them phase 3. Of 40 finished, 16 (40%) have results posted.
Among the 50 studies in Renal Insufficiency, Chronic by AstraZeneca, this one is the 4th largest by planned enrollment of the 34 interventional ones that give a count, is one of 5 that started in 2026, is one of 8 in phase 3, and was the 49th registered.
AstraZeneca’s Renal Insufficiency, Chronic studies by the year they started, since 2003.
6 of the studies testing dapagliflozin in Renal Insufficiency, Chronic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05374291Phase 3University Medical Center GroningenThe RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD | 2027-07 |
| NCT07222917AstraZenecaA Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. | 2026-12-10 |
| NCT06155604The University of Hong KongSGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease | 2026-12-31 |
| NCT07678203Hospital Civil Juan I. MenchacaDapagliflozin to Reduce the Decline in Renal Function in Patients Newly Diagnosed With Lupus Nephritis | 2027-01-28 |
| NCT07405216Centenario Hospital Miguel HidalgoEfficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease | 2027-05-30 |
Among the 40 studies testing dapagliflozin in Renal Insufficiency, Chronic, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 50 in Renal Insufficiency, Chronic:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC.
This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.
This is a Phase III, multicentre, randomised, double-blind, double-dummy, parallel-group, active-controlled, event-driven study in participants with CKD Stage 3b and 4.
The purpose of this study is to determine if balcinrenone/dapagliflozin, compared with dapagliflozin, administered as a capsule once daily on a background of standard of care (SoC) therapy, reduces the risk of CV death, death from kidney failure, kidney failure, sustained ≥ 50% decline from baseline in eGFR, and HF events in adults with CKD Stage 3b and 4. The study will also assess safety and tolerability of balcinrenone/dapagliflozin.
Eligible patients will randomly be assigned with a 1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of CKD and at least one of the following:
Exclusion Criteria:
T1DM, except:
Any use of the following medications and supplements:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin.
Drug: Balcinrenone/dapagliflozin · Drug: Placebo matching Dapagliflozin
Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg.
Drug: Dapagliflozin · Drug: Placebo matching balcinrenone/dapagliflozin
Drug pages: AZD9977 · Dapagliflozin
balcinrenone/dapagliflozin 15 mg/10 mg
dapagliflozin 10 mg
matching placebo for dapagliflozin 10 mg
matching placebo for balcinrenone/dapagliflozin
Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event
Time from randomization to first occurrence of any of the components of the composite: * CV death * Death from kidney failure * Onset of kidney failure * Initiation of maintenance dialysis or * Kidney transplantation * Sustained ≥ 50% decline from baseline in eGFR * HF with or without hospitalisation
Time frame: Up to 46 months.
Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR.
Time from randomization to first occurrence of any of the components of the composite: * CV death * Death from kidney failure * Onset of kidney failure: * Initiation of maintenance dialysis or * Kidney transplantation Sustained ≥ 50% decline from baseline in eGFR
Time frame: Up to 46 months.
Change in urinary albumin to creatinine ratio to Week 24
Change from baseline to Week 24 in urinary albumin to creatinine ratio
Time frame: Baseline to Week 24
Time to first occurrence of cardiovascular death or heart failure event.
Time from randomization to first occurrence of any of the components of the composite: * CV death * HF with or without hospitalisation
Time frame: Up to 46 months.
Time to cardiovascular death
Time from randomization to cardiovascular death.
Time frame: Up to 46 months.
Time to death from any cause
Time from randomization to death from any cause.
Time frame: Up to 46 months.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 478 sites across 27 countries. Choose a country and city above to see the rest.
Plan to share: No — Researchers may see summary results, but they will not be able to see individual participant data or any personal identifiers.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jul 2030, 46 months after the start.
Of 104 industry-sponsored phase 3 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 46 months is above that.
Counting every sponsor, half of 145 studies reached it within 33 months; a quarter within 19 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: AZD9977 · Dapagliflozin
Renal Insufficiency, Chronic →