The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
ConditionMuscle-Invasive Bladder Carcinoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University
About this trial
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
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Metformin Hydrochloride 500 MG
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov