Adrenocorticotropic Hormone (ACTH) for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome
Public ClinicalTrials.gov record NCT02132195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In childhood nephrotic syndrome, the kidneys leak protein, causing body swelling and a variety of possible complications such as infection, blood clots, and kidney failure. The first-line treatment for nephrotic syndrome is corticosteroids. Many children respond to prednisone treatment, but the disease comes back (relapses) when the prednisone is stopped or the dose is reduced. Children with frequently relapsing or steroid dependent nephrotic syndrome are at risk for toxicity from frequent exposure to corticosteroids. Currently, the standard treatment for frequently relapsing and steroid dependent nephrotic syndrome involves a variety of medications that suppress the immune system, which can produce serious side effects. We propose a study to examine the effects of a different medication, ACTH, on nephrotic syndrome. ACTH is a hormone naturally found in the body. Recently, in adult studies, ACTH has been shown to be effective for the treatment of nephrotic syndrome. It has also been shown to have mild and reversible side effects. ACTH is potentially an attractive therapeutic alternative for the treatment of frequently relapsing and steroid dependent nephrotic syndrome in children. Our study will randomly assign patients with frequently relapsing or steroid dependent nephrotic syndrome to either ACTH treatment or no treatment. This will allow us to study the effects of ACTH on this disease and its side effects, by comparing how patients do on ACTH treatment versus no treatment. We hypothesize that ACTH gel is superior to no treatment in maintaining remission in children with frequently relapsing or steroid dependent nephrotic syndrome.
Study identification
- NCT ID
- NCT02132195
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 31 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2014 (Actual)
- Primary completion
- Jan 2018 (Actual)
- Completion
- Mar 2018 (Actual)
- Last update posted
- May 29, 2019
2014 – 2018
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pediatric Nephrology of Alabama, PC. | Birmingham | Alabama | 35205 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| Nemours/AI duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Boston Children's Hopsital | Boston | Massachusetts | 02115 | — |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Children's Mercy | Kansas City | Missouri | 64109 | — |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Duke Children's Health Center | Durham | North Carolina | 27704 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02132195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 29, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02132195 live on ClinicalTrials.gov.