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NCT Number: NCT07156786

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

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.

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Key information

Conditions

Kidney Function Issue Acetylcysteine Adverse Reaction Acute Kidney Injury Cancer (Solid Tumors) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Function Tests Male Urogenital Diseases Neoplasms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine (NAC)

Drug

N-Acetylcysteine effercescent 1200 mg orally twice a day for 7 days. One day before cisplatin based chemotherapy, on the chemotherapy day, and five days after.

Placebo

Drug

Patient will get placebo

Primary outcomes

Kidney injury molecule-1

Time frame: 1 week and 3 weeks after intervention

Detected from participants urine sample indicating kidney function, will be measured at baseline, and after the intervention
Creatinine

Time frame: 1 week and 3 weeks after intervention

Creatinine will be measured from participants blood serum sample at baseline, and after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Oryza G Prabu, MD, Specialist

CONTACT

[email protected]

+62 821 1113 3822

Pringgodigdo Nugroho, MD, Doctor

CONTACT

[email protected]

+62 817 9822 504

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Registry information

Official study title

N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 5, 2025
Registry last updated: Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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