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

NCT ID: NCT07156786

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-08-31

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.

Conditions

Kidney Function Issue; Acute Kidney Injury; Cancer (Solid Tumors); Kidney Function Tests; Acetylcysteine Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Patient receiving placebo and cisplatin chemotherapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patient will get placebo

N-Acetylcysteine

Patient receiving NAC + cisplatin based chemotherapy

Group Type: EXPERIMENTAL

N-acetylcysteine (NAC)

Intervention Type: 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.

Interventions

N-acetylcysteine (NAC)

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.

Intervention Type: DRUG

Placebo

Patient will get placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Oryza Gryagus Prabu, MD

Medical Staff, Internist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Oryza G Prabu, MD, Specialist

Role: CONTACT

oryza.gyragus@gmail.com

+62 821 1113 3822

Pringgodigdo Nugroho, MD, Doctor

Role: CONTACT

pringgo@gmail.com

+62 817 9822 504

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

25-02-0179

Identifier Type: -

Identifier Source: org_study_id