Clinical trial · Interventional
The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
NCT06215976CI-TRIAL-00079938unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are: * To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer. * To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hydrochloride 500 MG | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin
- description
- (39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol
- interventionNames
- Drug: Metformin Hydrochloride 500 MG
- type
- NO_INTERVENTION
- label
- Control
- description
- (39) patients taking cisplatin (70 mg/m2) gemcitabine (1000 mg/m2) (GC) protocol without metformin
Primary outcomes (4)
- measure
- serum creatinine (SCr)
- timeFrame
- 12 week
- description
- to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Non-diabetic adults of age between 18 to 65. 2. Chemotherapy naïve patients diagnosed with bladder cancer. 3. Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2 Exclusion Criteria: 1. Patients with history of lactic acidosis. 2. Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin). 3. Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification 4. Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock). 5. Severe infection and sepsis. * Any infection requiring hospitalization. * Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure. 6. Alcohol intake. 7. Respiratory failure. 8. Severe hepatic impairment (Child-Pugh class C). 9. Patients with metastasis.
References
Publications (1)
- DERIVEDMahran SE, Salem SE, Sabry NA, Farid SF. The nephroprotective effect of metformin with cisplatin in bladder cancer: randomized clinical trial. Int Urol Nephrol. 2025 Nov;57(11):3611-3624. doi: 10.1007/s11255-025-04505-2. Epub 2025 May 3. PMID 40319155