Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

NCTNCT02057523Other id2013-0764

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Unable to enroll patients, no longer at institution.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 2 participants (actual)
Sponsor: University of Illinois at Chicago · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Sept 2014
Primary completion: Mar 2015
Completion: Sept 2015
First posted: 7 Feb 2014 (estimated)
Last update posted: 4 Sept 2020
Conditions: Proteinuria · Transplant Glomerulopathy

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420152016

Ph 4
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
NCT02057523
Sept 2014 to Sept 2015
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.

Interventions

ActharDrug

Arms1

Experimental
Acthar
Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

50% Reduction in Proteinuria or Proteinuria < 150mg/Day
Time frame · 6 months

Secondary outcomes(1)

25% Improvement in the MDRD eGFR
Time frame · 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 6 months

50% Reduction in Proteinuria or Proteinuria < 150mg/Day

Group	Value (Participants)
Acthar	1

Secondary and other outcome results(1)

Secondary outcomeCount of participants· 6 months

25% Improvement in the MDRD eGFR

Group	Value (Participants)
Acthar	1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ActharActhar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.	0 / 2	0 / 2	0 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy. * Failed standard therapy (\>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression Exclusion Criteria: * Diabetes

PepBank is a research reference. Talk to a doctor before you use any peptide.