RecruitingPhase 4

The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Egypt78 participantsStarted 2023-06-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✕. Alcohol intake.
✕. Respiratory failure.
✕. Severe hepatic impairment (Child-Pugh class C).

What they're measuring

serum creatinine (SCr)

Timeframe: 12 week

Human Neutrophil gelatinase-associated lipocalin (NGAL)

Timeframe: 12 week

Cystatin C

Timeframe: 12 week

Estimated glomerular filtration rate (eGFR)

Timeframe: 12 week

Trial details

NCT IDNCT06215976

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

Contact for this trial

Samah Essam Saber Mahran

0201094164048 samah.essam@pharma.cu.edu.eg

View on ClinicalTrials.gov More Muscle-Invasive Bladder Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✕. Alcohol intake.
✕. Respiratory failure.
✕. Severe hepatic impairment (Child-Pugh class C).