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The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Recruiting
18-65 years
All
Phase 4

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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

Eligibility

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.

Study details
    Muscle-Invasive Bladder Carcinoma

NCT06215976

Cairo University

29 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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