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Recruiting NCT06215976

The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Phase IV Interventional Muscle-Invasive Bladder Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin Hydrochloride 500 MG.
Who it may be relevant to
Registry conditions: Muscle-Invasive Bladder Carcinoma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Metformin Hydrochloride 500 MG
    Metformin 500mg tablets twice daily

Primary outcome measures

  • serum creatinine (SCr) [Time frame: 12 week]
  • Human Neutrophil gelatinase-associated lipocalin (NGAL) [Time frame: 12 week]
  • Cystatin C [Time frame: 12 week]
  • Estimated glomerular filtration rate (eGFR) [Time frame: 12 week]
Secondary outcome measures (6)
  • FBG [Time frame: 12 week]
  • HbA1C [Time frame: 12 week]
  • Body weight [Time frame: 12 week]
  • Body Mass Index [Time frame: 12 week]
  • Blood pH [Time frame: 12 week]
  • Blood Lactate Level [Time frame: 12 week]

Eligibility criteria

Inclusion criteria

  • Non-diabetic adults of age between 18 to 65.
  • Chemotherapy naïve patients diagnosed with bladder cancer.
  • Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2

Exclusion criteria

  • Patients with history of lactic acidosis.
  • Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).
  • 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
  • Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).
  • Severe infection and sepsis.
  • Any infection requiring hospitalization.
  • Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure.
  • Alcohol intake.
  • Respiratory failure.
  • Severe hepatic impairment (Child-Pugh class C).
  • Patients with metastasis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Egypt · 1 center
  • faculty of pharmacy Cairo university — Cairo

Publications

  • Mahran 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

Identifiers

NCT: NCT06215976 · CL (3164)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗