Clinical Trial

N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creatinine on Cancer Patients With Cisplatin Based Chemotherapy: A Randomized Placebo-Controlled Trial

Not Yet Recruiting Phase 2/3
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Summary
The goal of this clinical trial is to learn if N-Acetylcysteine drug works to protect kidney function in adults patient with cancer. Kidney function will be measured by laboratory parameter using urine sample (KIM-1 urine) and blood sample (serum creatinine). The main questions it aims to answer are: 1. Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection? 2. Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection? Participants will: 1. Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo) 2. Underwent cisplatin based chemotherapy 3. Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy) 4. Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy) 5. Had their symptoms monitor during and after taking the drugs. Every possible side effect, hospitalization, or death will be recorded.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-04.
Trial Details
NCT Number NCT07156786
Lead Sponsor Fakultas Kedokteran Universitas Indonesia
Conditions Kidney Function Issue, Acute Kidney Injury, Cancer (Solid Tumors), Kidney Function Tests, Acetylcysteine Adverse Reaction
Enrollment 72 participants
Start Date 2025-09-15
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-19