Not Yet RecruitingPhase 2/3

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

72 participantsStarted 2025-09-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Kidney injury molecule-1

Timeframe: 1 week and 3 weeks after intervention

Creatinine

Timeframe: 1 week and 3 weeks after intervention

Trial details

NCT IDNCT07156786

SponsorFakultas Kedokteran Universitas Indonesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Oryza G Prabu, MD, Specialist

+62 821 1113 3822 oryza.gyragus@gmail.com

View on ClinicalTrials.gov More Kidney Function Issue trials