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NCT06838416: KSD-01
Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease
trial testing Finerenone in Type 2 Diabetes Mellitus in 300 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Second Affiliated Hospital of Soochow University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 17 November 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Finerenone (FINERENONE) — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
- Renal Function — all drugs for Renal Function →
Sponsor
Second Affiliated Hospital of Soochow University
Who can join
18 and older, any sex, with Type 2 Diabetes Mellitus or Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Research Objectives To evaluate the impact of finerenone on renal function, diabetic complications, and safety in patients with Type 2 diabetes and chronic kidney disease. Study Design Type: Prospective, single-arm, multicenter clinical trial. Sample Size: 300 patients. Intervention: Finerenone added to existing treatment regimen (10-20 mg once daily, dose adjusted based on eGFR), for 48 weeks. Data Collection Time Points: Baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. Primary Endpoint: Change in urine albumin-to-creatinine ratio (UACR). Secondary Endpoints: Changes in eGFR, 24-hour urine protein, serum uric acid, retinopathy markers, pulse wave velocity (PWV), ankle-brachial index (ABI), etc. Safety Endpoints: Changes in serum potassium, sodium, and blood pressure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06838416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Finerenone
Trials testing the same drug.
- NCT07547878 — Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) · Phase 4 · not yet recruiting
- NCT07351864 — Finerenone Plus SGLT2 Inhibitors in Heart Failure · Phase 4 · not yet recruiting
- NCT07326631 — Finerenone for Cardiorenal Protection in Diabetic CKD: Impact on Renal Function Decline and Heart Failure · NA · not yet recruiting
- NCT07235891 — Retinal Protective Effects of Novel Finerenone in Patients With Chronic Kidney Disease · Phase 4 · not yet recruiting
- NCT07056595 — Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial · NA · recruiting
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
- NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
- NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
- NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
- NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
- NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting
Other Second Affiliated Hospital of Soochow University trials
Trials by the same sponsor.
- NCT07327411 — Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors · Phase 2 · not yet recruiting
- NCT07241897 — DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes · Phase 3 · not yet recruiting
- NCT07267234 — PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0) · Phase 2 · not yet recruiting
- NCT07095790 — Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke · Phase 4 · recruiting
- NCT07002502 — Immune Modulation With PRaG-1 Treatment · Phase 2 · not yet recruiting
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 NCT06838416 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital of Soochow University
- Last refreshed: 4 April 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/NCT06838416.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing