Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.

What Was Tested

The trial (phase 3) is built around ACTH (Corticotropin).

Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse/steroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of such patients.

It had two arms (groups): Adrenocorticotrophic Hormone Group (experimental) and Steroid Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Although the treatment of steroids with immunosuppressive agents is a new choice for the treatment of such patients, traditional immunosuppressive agents will bring some serious irreversible side effects.

In recent years, the new mechanism of action of ACTH is also being explored.

Who Took Part

The registry lists 140 planned participants were the target.

It was open to people of any sex aged from 2 years up to 14 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 2-14 years old;. Sensitive but frequent relapses or steroids dependence nephrotic syndrome.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;; recurrent or persistent hypertension;; secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-11-01 with completion listed for 2026-06-30.

It ran at 8 sites in China (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Recurrence-free survival time(day) within 48 weeks (time frame: Within 48 weeks after randomization).

It also tracked 8 secondary outcomes, for example Number of relapses during 48 weeks follow up, The first time to relapse, Change in renal function of the patients, Change in anthropometry and growth velocity during 48 weeks after randomization, Change in serum cholesterol, hemoglobin and blood albumin of the patients and Incidence of infection.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of ACTH (Corticotropin) in 140 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.