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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryNumber of Participants Experienced a Relapse of Nephrotic Syndrome6 monthsNumber of participants experienced a relapse of nephrotic syndrome during the initial 6 months of the study.
SecondaryNumber of Participants Experiencing Relapses After Dose Reduction of ACTH6 to 12 monthsThe dose of ACTH will be reduced by 50% after 6 months and the rate of relapse during this period will be evaluated.
SecondaryNumber of Adverse Events12 monthsAdverse events will be collected (SAEs and AEs)

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants Experienced a Relapse of Nephrotic Syndrome6 monthsThe primary outcome measure was accessed during the initial 6 months based on initial assignment, rescue therapy group was not part of the analysis.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Relapses After Dose Reduction of ACTH6 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
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Adverse Events12 months15 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 eventsNUMBER

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants Experienced a Relapse of Nephrotic SyndromeAdrenocorticotropic Hormone (ACTH)14Participants
Number of Participants Experienced a Relapse of Nephrotic SyndromeNo Treatment15Participants
Number of Participants Experiencing Relapses After Dose Reduction of ACTHAdrenocorticotropic Hormone (ACTH)0Participants
Number of Participants Experiencing Relapses After Dose Reduction of ACTHRescue Therapy0Participants
Number of Adverse EventsAdrenocorticotropic Hormone (ACTH)12number of events
Number of Adverse EventsNo Treatment4number of events
Number of Adverse EventsRescue Therapy17number of events

Participant flow18

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Initial AssignmentSTARTEDAdrenocorticotropic Hormone (ACTH)15
Initial AssignmentSTARTEDNo Treatment16
Initial AssignmentSTARTEDRescue Therapy0
Initial AssignmentCOMPLETEDAdrenocorticotropic Hormone (ACTH)1
Initial AssignmentCOMPLETEDNo Treatment16
Initial AssignmentCOMPLETEDRescue Therapy0
Initial AssignmentNOT COMPLETEDAdrenocorticotropic Hormone (ACTH)14
Initial AssignmentNOT COMPLETEDNo Treatment0
Initial AssignmentNOT COMPLETEDRescue Therapy0
Rescue TherapySTARTEDAdrenocorticotropic Hormone (ACTH)0

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherFlu and strep infectionsInfections and infestationsAdrenocorticotropic Hormone (ACTH)0150
otherFlu and strep infectionsInfections and infestationsNo Treatment0160
otherFlu and strep infectionsInfections and infestationsRescue Therapy3133
otherBehavioral changesSocial circumstancesAdrenocorticotropic Hormone (ACTH)2152
otherBehavioral changesSocial circumstancesNo Treatment0160
otherBehavioral changesSocial circumstancesRescue Therapy1131
otherSleep disturbancesNervous system disordersAdrenocorticotropic Hormone (ACTH)2152
otherSleep disturbancesNervous system disordersNo Treatment0160
otherSleep disturbancesNervous system disordersRescue Therapy2132
otherIncrease in blood pressureVascular disordersAdrenocorticotropic Hormone (ACTH)1152

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAdrenocorticotropic Hormone (ACTH)015
Total, all-cause mortalityNo Treatment016
Total, all-cause mortalityRescue Therapy013
Total, other adverse eventsAdrenocorticotropic Hormone (ACTH)415
Total, other adverse eventsNo Treatment216
Total, other adverse eventsRescue Therapy913
Total, serious adverse eventsAdrenocorticotropic Hormone (ACTH)315
Total, serious adverse eventsNo Treatment216
Total, serious adverse eventsRescue Therapy213

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
39513526DERIVED

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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