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NCT05884866: DapaBalci-Leap
A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Placebo on Body Fluid and Electrolyte Handling and Energy Metabolism in Participants Over 50 Years of Age With Chronic Kidney Disease.
Phase 2 trial testing Dapagliflozin 10mg Tab in Chronic Renal Failure in 100 participants. Currently enrolling.
31 January 2026
Quick facts
| Lead sponsor | Klinikum Nürnberg |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 13 July 2023 |
| Primary completion | 31 January 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 2 locations across France, Germany |
Drugs / interventions tested
- Dapagliflozin 10mg Tab — full drug profile →
- Balcinrenone 50mg Capsule — full drug profile →
- Balcinrenone 100mg Capsule
- Dapagliflozin matching Placebo — full drug profile →
- Balcinrenone 50mg matching Placebo — full drug profile →
- Balcinrenone 100mg matching Placebo — full drug profile →
Conditions studied
- Chronic Renal Failure — all drugs for Chronic Renal Failure →
- Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis — all drugs for Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis →
- Chronic Kidney Disease Stage 3 — all drugs for Chronic Kidney Disease Stage 3 →
- Electrolyte and Fluid Balance Conditions — all drugs for Electrolyte and Fluid Balance Conditions →
Sponsor
Klinikum Nürnberg — full company profile →
Who can join
50 and older, any sex, with Chronic Renal Failure or Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to investigate the mechanistic effects of dapagliflozin 10 mg, alone or in combination with balcinrenone 150 mg, with balcinrenone 150 mg and placebo, on the way the body handles electrolytes and water content, as well as the effects these interventions may have on energy metabolism in participants with stage 3 chronic kidney disease. The study interventions will be administered orally, daily, in addition to current therapy, for a duration of 28 days. This will allow us to maximize our ability to detect a drug effect while minimizing the drop-out rate that accompanies longer studies. In order to understand the different mechanistic effects of these interventions on energy metabolism, the study will be conducted at two study sites. The study design and treatment allocation, treatment duration as well as sample analysis for evaluation of the primary endpoint will be identical for all participants, at both sites. Therefore, urine and plasma samples for analysis of water and electrolyte handling will be collected from all study participants at both sites. In addition to the primary endpoint, the main study site (Nuremberg) will conduct a metabolic study to investigate the early- and late-effects of the interventions, while the second site, Marseille, will conduct an imaging sub-study to assess changes at the tissue level before and after treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Potential Role of Mineralocorticoid Receptor Antagonists in Nondiabetic Chronic Kidney Disease and Glomerular Disease.
Zachariah T, Radhakrishnan J. · · 2024 · cited 5× · PMID 39037799 · DOI 10.2215/cjn.0000000000000540
Verify or expand the search:
- PubMed search for NCT05884866
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05884866 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Klinikum Nürnberg
- Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05884866.
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