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NCT Number: NCT06215976

The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of pharmacy Cairo university

Cairo, Egypt

Location status: Recruiting

Location contact

Samah Essam Saber Mahran

CONTACT

[email protected]

0201094164048

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin Hydrochloride 500 MG

Drug

Metformin 500mg tablets twice daily

Primary outcomes

  1. serum creatinine (SCr)

    Time frame: 12 week

    to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.

  2. Human Neutrophil gelatinase-associated lipocalin (NGAL)

    Time frame: 12 week

    to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

  3. Cystatin C

    Time frame: 12 week

    to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

  4. Estimated glomerular filtration rate (eGFR)

    Time frame: 12 week

    to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

Secondary outcomes

  1. FBG

    Time frame: 12 week

    to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin

  2. HbA1C

    Time frame: 12 week

    to assess the safety of using cisplatin-metformin combination in bladder cancer patients

  3. Body weight

    Time frame: 12 week

    to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)

  4. Body Mass Index

    Time frame: 12 week

    to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)

  5. Blood pH

    Time frame: 12 week

    to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)

  6. Blood Lactate Level

    Time frame: 12 week

    to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)

Study contacts

Contact information is provided by the study sponsor or research team.

Samah Essam Saber Mahran

CONTACT

[email protected]

0201094164048

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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