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 Applicable

Not yet recruiting

• Conditions: Kidney Function Issue; Acute Kidney Injury; Cancer (Solid Tumors); Kidney Function Tests; Acetylcysteine Adverse Reaction
• Interventions: Drug: Placebo; Drug: N-acetylcysteine (NAC)

• Registration Number: NCT07156786
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-24
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2027-04-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patient receiving placebo and cisplatin chemotherapy
N-Acetylcysteine	N-acetylcysteine (NAC)	Patient receiving NAC + cisplatin based chemotherapy

Primary Outcome Measures

Name	Time	Method
Kidney injury molecule-1	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	1 week and 3 weeks after intervention	Creatinine will be measured from participants blood serum sample at baseline, and after intervention