Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar

Short name TGActhar

NCTNCT02546492Other idHP-00063872

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Slow Enrollment

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 6 participants (actual)
Sponsor: University of Maryland, Baltimore · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Aug 2016
Primary completion: 27 May 2021
Completion: 27 May 2021
First posted: 11 Sept 2015 (estimated)
Last update posted: 6 Oct 2022
Conditions: Transplant Glomerulopathy

Timeline

1 trial · 1 stopped early · 1 with posted results

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

2016201720182019202020212022

Ph 4
TGActhar
NCT02546492
Aug 2016 to 27 May 2021
Terminated
Terminated

Registry summary

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

This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in patients with chronic antibody-mediated rejection (CAMR).

Interventions

Acthar gelDrug

Arms1

Experimental
Acthar
The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.

Primary outcomes1

Outcomes the sponsor listed as primary.

Safety (Serious Adverse Events)
Time frame · 12 months
Registry description
Participants will be monitored for Serious Adverse Events, as follows (as described in ClinicalTrials.gov) Death, Life-threatening events, Hospitalization (initial or prolonged), Disability and events that requires intervention to prevent permanent impairment or damage. Other (non serious) events which were anticipated or unanticipated (as described in ClinicaTrials.gov) will be monitored. ASSESSMENT: The subjects will be assessed at regular intervals through a questionnaire for Acthar related events, physician evaluation at clinical visits, and self reporting.

Secondary outcomes(1)

Efficacy Outcome
Time frame · 1 year
Registry description
composite of graft loss, death, decrease in eGFR\>10%, and increase in proteinuria

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· 12 months

Safety (Serious Adverse Events)

Group	Value (Participants)
Serious Adverse Events (SAE)	2

Secondary and other outcome results(1)

Secondary outcomeCount of participants· 1 year

Efficacy Outcome

Group	Value (Participants)
Efficacy Outcomes	3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Participants Received ActharAll participants in the study received Acthar.	1 / 6	2 / 6	1 / 6

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: * Age \>18 years * Morphologic diagnosis of CAMR, by light \&/or electron microscopy any time after transplantation * Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse peritubular capillary C4d staining by immunohistochemistry * eGFR\>25 ml/min Exclusion Criteria: * Diagnosis of malignancy within a year prior to enrollment (except cured cutaneous basal cell or squamous cell carcinoma). * Lack of evidence of antibody involvement * Pregnancy, lactation, or refusal to use birth control in women of child bearing potential * Active infection, or history of HIV * History of liver or thoracic transplant

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