N-Acetylcysteine Roles in Preserving Renal Function Measu... | NCT07156786

Studies
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

Sponsor

Fakultas Kedokteran Universitas Indonesia

Status

Not yet recruiting

Last Update Posted

Sep 19, 2025Actual

Enrollment

72Estimated

Phase

Phase 2Phase 3

Conditions

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

Interventions

N-acetylcysteine (NAC)
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2025Estimated

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

Aug 31, 2027Estimated

First Submitted Date

Aug 24, 2025

First Submission Date that Met QC Criteria

Sep 4, 2025

First Posted Date

Sep 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2025

Last Update Posted Date

Sep 19, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oryza Gryagus Prabu, MD, Medical Staff, Internist, Fakultas Kedokteran Universitas IndonesiaPrincipal Investigator

Lead Sponsor

Fakultas Kedokteran Universitas IndonesiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection?
Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection?

Participants will:

Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo)
Underwent cisplatin based chemotherapy
Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy)
Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy)
Had their symptoms monitor during and after taking the drugs. Every possible side effect, hospitalization, or death will be recorded.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Due to privacy regulations and institutional policy, individual participant data will not be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 12, 2025

ID	Term
D058186	Acute Kidney Injury
D009369	Neoplasms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins