Status:
RECRUITING
The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
Lead Sponsor:
Cairo University
Conditions:
Muscle-Invasive Bladder Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 determ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06215976
Start Date
June 1 2023
End Date
December 30 2024
Last Update
August 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
faculty of pharmacy Cairo university
Cairo, Egypt