Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Fakultas Kedokteran Universitas Indonesia
Conditions:
Kidney Function Issue
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 urin...
Eligibility Criteria
Inclusion
- Patient with cancer/ malignancy proven by histopathological examination
- Patient with GFR ≥60 ml/mins/1,73 m²
- Patient with normal complete blood count and liver function test result
- Patient with good performance status (Karnofsky score ≥80)
- Patients with cisplatin based chemotherapy
Exclusion
- Patient that can not tolerate N-Acetylcysteine usage
- Patient with history of hypersensitivity to N-Acetylcysteine
- Patient that given other potentially nephrotoxic drug, such as furosemide, non-steroidal anti-infammatory drugs, aminoglycosides, amphotericin B, cephalosporine
- Patient that given other chemotherapy drug, such as permetrexed, ifosfamide, gemcitabin, bevacizumab, cetuxsimab
- Patient with history of malignant or uncontrolled hypertension
- patient with congestive heart failure, kidney structure abnormality, and acute infection
- Pregnant or lactating women
- Patient refusing to participate in the research
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07156786
Start Date
September 15 2025
End Date
August 31 2027
Last Update
September 19 2025
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