The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Last updated: August 19, 2024
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

4

Condition

Bladder Cancer

Urothelial Cancer

Treatment

Metformin Hydrochloride 500 MG

Clinical Study ID

NCT06215976
CL (3164)
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 orgreater 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 fluidsto support blood pressure.

  1. Alcohol intake.

  2. Respiratory failure.

  3. Severe hepatic impairment (Child-Pugh class C).

  4. Patients with metastasis.

Study Design

Total Participants: 78
Treatment Group(s): 1
Primary Treatment: Metformin Hydrochloride 500 MG
Phase: 4
Study Start date:
June 01, 2023
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • faculty of pharmacy Cairo university

    Cairo,
    Egypt

    Active - Recruiting

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