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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06215976
Other study ID # CL (3164)
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2023
Est. completion date December 30, 2024

Study information

Verified date January 2024
Source Cairo University
Contact Samah Essam Saber Mahran
Phone 0201094164048
Email samah.essam@pharma.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date December 30, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metformin Hydrochloride 500 MG
Metformin 500mg tablets twice daily

Locations

Country Name City State
Egypt faculty of pharmacy Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum creatinine (SCr) to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity. 12 week
Primary Human Neutrophil gelatinase-associated lipocalin (NGAL) to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity 12 week
Primary Cystatin C to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity 12 week
Primary Estimated glomerular filtration rate (eGFR) to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity 12 week
Secondary FBG to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin 12 week
Secondary HbA1C to assess the safety of using cisplatin-metformin combination in bladder cancer patients 12 week
Secondary Body weight to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss) 12 week
Secondary Body Mass Index to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss) 12 week
Secondary Blood pH to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any) 12 week
Secondary Blood Lactate Level to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any) 12 week
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