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 range

18 Years – 65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 65 Years

Sex

ALL

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