NCT06215976 The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
| NCT ID | NCT06215976 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cairo University |
| Condition | Muscle-Invasive Bladder Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2024-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 78 participants in total. It began in 2023-06-01 with a primary completion date of 2024-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: 1. Non-diabetic adults of age between 18 to 65. 2. Chemotherapy naïve patients diagnosed with bladder cancer. 3. Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2 Exclusion Criteria: 1. Patients with history of lactic acidosis. 2. Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin). 3. 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 4. Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock). 5. Severe infection and sepsis. * Any infection requiring hospitalization. * Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure. 6. Alcohol intake. 7. Respiratory failure. 8. Severe hepatic impairment (Child-Pugh class C). 9. Patients with metastasis.
Contact & Investigator
Samar Farid
STUDY CHAIR
faculty of pharmacy Cairo University
Frequently Asked Questions
Who can join the NCT06215976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Muscle-Invasive Bladder Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06215976 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06215976 currently recruiting?
Yes, NCT06215976 is actively recruiting participants. Contact the research team at samah.essam@pharma.cu.edu.eg for enrollment information.
Where is the NCT06215976 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06215976 clinical trial?
NCT06215976 is sponsored by Cairo University. The principal investigator is Samar Farid at faculty of pharmacy Cairo University. The trial plans to enroll 78 participants.