Kidney Function IssuePhase 2/3NCT07156786
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
A Phase 2/3 study testing N-acetylcysteine (NAC) in people with Kidney Function Issue and Acute Kidney Injury, run by Fakultas Kedokteran Universitas Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Function Issue, Acute Kidney Injury, Cancer (Solid Tumors)
- What is being tested?
- N-acetylcysteine (NAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 31 Aug 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy
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?
Read more
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.
- Conditions
- Kidney Function Issue, Acute Kidney Injury, Cancer (Solid Tumors), Kidney Function Tests, Acetylcysteine Adverse Reaction
- Being tested
- N-acetylcysteine (NAC), Placebo
- Keywords
- kidney injury molecule 1, KIM-1, Creatinine, N-Acetylcysteine
- Medical subject headings
- Acute Kidney Injury, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Patient will get placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patient receiving placebo and cisplatin chemotherapy Receives: Drug: Placebo |
| N-Acetylcysteine | Experimental | Patient receiving NAC + cisplatin based chemotherapy Receives: Drug: N-acetylcysteine (NAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney injury molecule-1
Detected from participants urine sample indicating kidney function, will be measured at baseline, and after the intervention
Measured: 1 week and 3 weeks after intervention
Creatinine
Creatinine will be measured from participants blood serum sample at baseline, and after intervention
Measured: 1 week and 3 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oryza Gryagus Prabu, MD, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156786
- Sponsor's protocol ID
- 25-02-0179
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy regulations and institutional policy, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy
- ClinicalTrials.gov ID
- NCT07156786
- Acronym / sponsor ID
- 25-02-0179
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatient receiving placebo and cisplatin chemotherapy |
| N-Acetylcysteine | Experimental | Drug: N-acetylcysteine (NAC)Patient receiving NAC + cisplatin based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | N-Acetylcysteine |
| PlaceboPatient will get placebo | Drug | Placebo |
Primary outcome
Kidney injury molecule-1
Time frame: 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
Time frame: 1 week and 3 weeks after intervention
Creatinine will be measured from participants blood serum sample at baseline, and after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. Due to privacy regulations and institutional policy, individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing N-acetylcysteine (NAC) in people with Kidney Function Issue and Acute Kidney Injury, run by Fakultas Kedokteran Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oryza G Prabu, MD, Specialist (+62 821 1113 3822, oryza.gyragus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney injury molecule-1 (time frame: 1 week and 3 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.