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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-09-19

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Placebo

Patient will get placebo

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-04-30
Completion
2027-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156786 on ClinicalTrials.gov