Trial · NCT02132195
Adrenocorticotropic Hormone (ACTH) for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome
NCT02132195, Phase 3, Completed, Emory University; results first posted 2019-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adrenocorticotropic Hormone (ACTH) for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome. Trials, record NCT02132195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02132195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adrenocorticotropic Hormone (ACTH) for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome
- NCT number
- NCT02132195
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Nephrotic Syndrome
- Interventions
- ACTH
- First posted
- 2014-05-07
- Last updated
- 2019-05-29
- Results first posted
- 2019-05-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experienced a Relapse of Nephrotic Syndrome | 6 months | Number of participants experienced a relapse of nephrotic syndrome during the initial 6 months of the study. |
| Secondary | Number of Participants Experiencing Relapses After Dose Reduction of ACTH | 6 to 12 months | The dose of ACTH will be reduced by 50% after 6 months and the rate of relapse during this period will be evaluated. |
| Secondary | Number of Adverse Events | 12 months | Adverse events will be collected (SAEs and AEs) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experienced a Relapse of Nephrotic Syndrome | 6 months | The primary outcome measure was accessed during the initial 6 months based on initial assignment, rescue therapy group was not part of the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Relapses After Dose Reduction of ACTH | 6 to 12 months | Three participants who completed 6 months of ACTH Full Dose therapy and then 6 months of Reduced Dose ACTH - inclusive of one subject initially randomized to ACTH and two subjects who received ACTH as rescue treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Adverse Events | 12 months | 15 pts randomized to receive ACTH, and 16 pts randomized to No-treatment. 13 patients in No-treatment arm elected to receive ACTH as rescue therapy. | number of events | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experienced a Relapse of Nephrotic Syndrome | Adrenocorticotropic Hormone (ACTH) | 14 | Participants | ||
| Number of Participants Experienced a Relapse of Nephrotic Syndrome | No Treatment | 15 | Participants | ||
| Number of Participants Experiencing Relapses After Dose Reduction of ACTH | Adrenocorticotropic Hormone (ACTH) | 0 | Participants | ||
| Number of Participants Experiencing Relapses After Dose Reduction of ACTH | Rescue Therapy | 0 | Participants | ||
| Number of Adverse Events | Adrenocorticotropic Hormone (ACTH) | 12 | number of events | ||
| Number of Adverse Events | No Treatment | 4 | number of events | ||
| Number of Adverse Events | Rescue Therapy | 17 | number of events |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Assignment | STARTED | Adrenocorticotropic Hormone (ACTH) | 15 | |
| Initial Assignment | STARTED | No Treatment | 16 | |
| Initial Assignment | STARTED | Rescue Therapy | 0 | |
| Initial Assignment | COMPLETED | Adrenocorticotropic Hormone (ACTH) | 1 | |
| Initial Assignment | COMPLETED | No Treatment | 16 | |
| Initial Assignment | COMPLETED | Rescue Therapy | 0 | |
| Initial Assignment | NOT COMPLETED | Adrenocorticotropic Hormone (ACTH) | 14 | |
| Initial Assignment | NOT COMPLETED | No Treatment | 0 | |
| Initial Assignment | NOT COMPLETED | Rescue Therapy | 0 | |
| Rescue Therapy | STARTED | Adrenocorticotropic Hormone (ACTH) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Flu and strep infections | Infections and infestations | Adrenocorticotropic Hormone (ACTH) | 0 | 15 | 0 |
| other | Flu and strep infections | Infections and infestations | No Treatment | 0 | 16 | 0 |
| other | Flu and strep infections | Infections and infestations | Rescue Therapy | 3 | 13 | 3 |
| other | Behavioral changes | Social circumstances | Adrenocorticotropic Hormone (ACTH) | 2 | 15 | 2 |
| other | Behavioral changes | Social circumstances | No Treatment | 0 | 16 | 0 |
| other | Behavioral changes | Social circumstances | Rescue Therapy | 1 | 13 | 1 |
| other | Sleep disturbances | Nervous system disorders | Adrenocorticotropic Hormone (ACTH) | 2 | 15 | 2 |
| other | Sleep disturbances | Nervous system disorders | No Treatment | 0 | 16 | 0 |
| other | Sleep disturbances | Nervous system disorders | Rescue Therapy | 2 | 13 | 2 |
| other | Increase in blood pressure | Vascular disorders | Adrenocorticotropic Hormone (ACTH) | 1 | 15 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adrenocorticotropic Hormone (ACTH) | 0 | 15 |
| Total, all-cause mortality | No Treatment | 0 | 16 |
| Total, all-cause mortality | Rescue Therapy | 0 | 13 |
| Total, other adverse events | Adrenocorticotropic Hormone (ACTH) | 4 | 15 |
| Total, other adverse events | No Treatment | 2 | 16 |
| Total, other adverse events | Rescue Therapy | 9 | 13 |
| Total, serious adverse events | Adrenocorticotropic Hormone (ACTH) | 3 | 15 |
| Total, serious adverse events | No Treatment | 2 | 16 |
| Total, serious adverse events | Rescue Therapy | 2 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39513526 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02132195
GET https://conductscience.org/api/trials/v1/NCT02132195/events?page=2