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

NCT07156786 | Not Yet Recruiting Phase 2

• 1 other identifier: 25-02-0179
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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. 1.Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection?
2. 2.Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection?
3. 3.Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo)
4. 4.Underwent cisplatin based chemotherapy
5. 5.Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy)
6. 6.Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy)
7. 7.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

Keywords

kidney injury molecule 1; KIM-1; Creatinine; N-Acetylcysteine

Outcome Measures

Primary Outcomes (2)

• Kidney injury molecule-1

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

  1 week and 3 weeks after intervention

• Creatinine

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

  1 week and 3 weeks after intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patient receiving placebo and cisplatin chemotherapy

Drug: Placebo

N-Acetylcysteine

EXPERIMENTAL

Patient receiving NAC + cisplatin based chemotherapy

Drug: N-acetylcysteine (NAC)

Interventions

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.

N-Acetylcysteine

Placebo DRUG

Patient will get placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

MeSH Terms

Conditions

Acute Kidney Injury; Neoplasms

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Oryza G Prabu, MD, Specialist

CONTACT

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

Pringgodigdo Nugroho, MD, Doctor

CONTACT

+62 817 9822 504; pringgo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff, Internist

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 5, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share