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Can a common antioxidant shield kidneys from leptospirosis?

NCT ID NCT07821853

Symptom relief Sponsor: Dr Cipto Mangunkusumo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether oral N-acetylcysteine (NAC) can reduce signs of kidney tubular injury, oxidative stress, and inflammation in adults with non-severe leptospirosis. The trial enrolls 64 adults who have had fever for three to five days and a confirmed Leptospira infection. Participants receive either NAC 800 mg or a placebo three times daily for five days alongside standard treatment. The team measures changes in urinary KIM-1, serum ROS, and CRP from before treatment to Day 5.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N-acetylcysteine, an antioxidant supplement
What this could lead to
If it works, NAC could become a low-cost add-on that protects kidneys and calms inflammation in people with mild leptospirosis.
What could go wrong
This is a small Phase 2 trial measuring biomarker changes over five days, so it cannot show whether NAC prevents serious kidney problems or improves how patients feel. NAC can cause nausea or stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 years or older. * Fever onset on Day 3 to Day 5. * Non-severe leptospirosis (mild to moderate) according to WHO classification, confirmed serologically by a positive Leptospira IgM ELISA test. * No history of chronic kidney disease based on medical history, medical records, or kidney function assessment before the leptospirosis episode. * Willing to participate in the study and provide written informed consent. * No previous N-acetylcysteine therapy before randomization. Exclusion Criteria: * Severe leptospirosis or Weil's disease according to WHO classification. * Chronic kidney disease stage G3-G5 according to KDIGO classification. * Diabetes mellitus with diabetic nephropathy. * Uncontrolled or malignant hypertension. * Glomerulonephritis or other immunologic kidney disease. * Current use of potentially nephrotoxic medications, including aminoglycosides, non-steroidal anti-inflammatory drugs, chemotherapeutic agents, or other nephrotoxic drugs. * Severe chronic liver disease. * Severe heart disease or severe circulatory disorder. * Severe chronic pulmonary disease, including severe chronic obstructive pulmonary disease or uncontrolled persistent severe asthma. * Gastrointestinal disorders that may impair oral N-acetylcysteine absorption, including ileus, persistent vomiting, or severe malabsorption. * Pregnancy or breastfeeding. * History of hypersensitivity to N-acetylcysteine. * Refusal to participate or withdrawal of informed consent.

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Conditions

The condition(s) this trial relates to.

acute kidney injury Inflammation leptospirosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leptospirosis

Contacts and locations

Locations

  • RSUD Balaraja

    Tangerang, Banten, 15610, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.