UnknownNot Applicable

Evaluation of the Effect of Genetic Polymorphisms in ERCC1 and OCT2 on the Occurrence and Severity of Cisplatin-induced Nephrotoxicity

Egypt89 participantsStarted 2022-02-15

Plain-language summary

Approximately one-third of all patients treated with cisplatin develop renal dysfunction after a single dosage of cisplatin. Germline genetic polymorphisms may cause variations in cisplatin pharmacokinetics and in the ability of epithelial kidney cells to take up cisplatin and repair cisplatin-induced Deoxyribonucleic Acid (DNA) damage. Knowledge concerning which genotypes are associated with cisplatin-induced nephrotoxicity may help to identify at-risk patients and initiate strategies, such as using lower or fractionated cisplatin doses or avoiding cisplatin altogether, to prevent Acute Kidney Injury (AKI).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males or females aged \>18 years receiving cisplatin-containing chemotherapy. * A Cisplatin dose starting from 75 mg/m2 * Various cancer types * No history of organ transplantation or kidney dialysis. * Patients with normal renal function Exclusion Criteria: * Co-administration of ifosfamide with cisplatin, because of the known risk of nephrotoxicity. * Pregnant or lactation. * Infection with the human immunodeficiency virus (HIV). * Prior administration of cisplatin. * Intraperitoneal chemotherapy. * Inadequate liver function (bilirubin \> 1.5 times upper normal limit (UNL) and alanine transaminase (ALT) or aspartate transaminase (AST) \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases). * Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50 mL/min). * Serious comorbid systemic disorder incompatible with the study (uncontrolled diabetes mellitus (DM) or hypertension (HTN), myocardial infarction within the last 6 months). * Patients diagnosed with kidney cancer. * Exposure to any nephrotoxic drugs or agents.

What they're measuring

Serum Creatinine

Timeframe: Change from baseline at the end of cycle 1 (each cycle is 28 days)

Serum Creatinine

Timeframe: Change from baseline at the end of cycle 2 (each cycle is 28 days)

Trial details

NCT IDNCT05247671

SponsorAin Shams University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-15

Contact for this trial

Israa Abdelbar, BSc

00201013138111 israa.aly@bue.edu.eg