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Can a gentler steroid dose protect children's kidneys without the harsh side effects?

NCT ID NCT07719140

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial compares two starting doses of the steroid prednisone for children with lupus-related kidney inflammation (lupus nephritis). The standard high dose can cause serious side effects like growth problems and bone thinning. The study asks whether a lower initial dose can control the kidney disease just as well while reducing those harms. About 198 children aged 6 to 17 with confirmed lupus nephritis will be randomly assigned to either a low-dose or high-dose steroid regimen, and their kidney function will be measured after 24 weeks.

What this could mean

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

Active substance
prednisone (a corticosteroid) given at either a low or high starting dose
What this could lead to
If lower doses work as well as high doses, children with lupus nephritis could avoid severe steroid side effects like stunted growth and bone problems.
What could go wrong
This is a Phase 4 trial, but the lower dose might turn out to be less effective at controlling kidney inflammation, risking kidney damage.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 198 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

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

6 to 18 years

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: * Age ≥6 years and \<18 years, with body weight ≥20 kg * Meets the 2019 European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE) * Renal biopsy confirming Lupus Nephritis class III, IV, III+V, or IV+V according to the International Society of Nephrology / Renal Pathology Society (ISN/RPS) classification * At screening: 24-hour urinary protein ≥1.0 g (or ≥25 mg/kg), or urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g * White blood cell count ≥3.0 × 10⁹/L and lymphocyte count ≥1.0 × 10⁹/L * No prior intravenous methylprednisolone pulse therapy before enrollment, and glucocorticoid exposure ≤2 weeks before enrollment, with a maximum prednisone-equivalent dose ≤30 mg/day (or ≤1 mg/kg/day) * Written informed consent obtained and good treatment compliance expected Exclusion Criteria: * Uncertain diagnosis of SLE, genetically confirmed monogenic lupus, or a history of immunodeficiency * Severe infection, including hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, etc. * Severe neuropsychiatric lupus * Peripheral blood hemoglobin \<60 g/L, platelet count \<10 × 10⁹/L, or concomitant aplastic anemia * Severe cardiac insufficiency (NYHA functional class ≥ II) * Severe pulmonary involvement, including pulmonary hemorrhage, respiratory failure, pulmonary embolism, or other conditions requiring respiratory support * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² * Severe gastrointestinal bleeding, pancreatitis, or hepatic lesions * Patients deemed by the investigator to be unsuitable for participation in this trial

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Conditions

The condition(s) this trial relates to.

lupus nephritis pediatric systemic lupus erythematosus systemic lupus erythematosus

As listed by the trial registrant

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

Childhood-onset systemic lupus erythematosus Lupus nephritis (LN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Children's Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

  • Chidren's Hospital of Chongqing Medical University

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, China

  • Children's Hospital of Fudan University

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • Children's Hospital of Nanjing Medical University

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, China

  • Jilin University

    NOT_YET_RECRUITING

    Changchun, Jilin, China

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Shenzhen Children's Hospital

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, China

  • The Second Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

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