A Phase 4 interventional study of Acthar gel in Transplant Glomerulopathy, sponsored by University of Maryland, Baltimore. Terminated at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-06.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
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).
Subjects will receive Acthar® 40 units twice a week subcutaneously for 2 weeks. If the drug is well tolerated the dose will be increased to 80 units twice a week for another 22 weeks. The patients will be maintained on their center-specific standard maintenance regimen, typically consisting of Tacrolimus, mycephenolate mofetil/Sodium, and prednisone.
After screening for the inclusion/exclusion criteria, the patients will be consented and enrolled in the study. The initial visit and subsequent study-related visits at 4, 8, 12, 24, 36 and 52 weeks will include routine evaluation and physical examination and laboratory studies including CBC (complete blood count), electrolyte panel, eGFR, albumin, liver enzymes, and Calcineurin inhibitor (CNI)/sirolimus drug level, according to the center's standard of care. Donor-specific antibody (DSA) will be tested at week 24, and 52 and patients will undergo a biopsy at week 52, as a part of the investigators standard of care. The biopsies will be evaluated by light and electron microscopy using standard histological Banff criteria, and staining for CD68.
University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.
Drug: Acthar gel
Administration of the study drug in addition to the current maintenance immunosuppressive agents
Also known as: ACTH (Adrenocorticotropic hormone)
Safety (Serious Adverse Events)
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.
Time frame: 12 months
Efficacy Outcome
composite of graft loss, death, decrease in eGFR\>10%, and increase in proteinuria
Time frame: 1 year
| Milestone | Acthar |
|---|---|
| Started | 6 |
| Completed | 1 |
| Not completed | 5 |
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.
| Participants | Serious Adverse Events (SAE) |
|---|---|
| Safety (Serious Adverse Events) | 2 |
composite of graft loss, death, decrease in eGFR\>10%, and increase in proteinuria
| Participants | Efficacy Outcomes |
|---|---|
| Composite outcome | 3 |
| Death | 1 |
| Decreased GFR>10% | 1 |
| Increased proteinuria | 1 |
Collected over 12 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants Received Acthar | 1/6 (16.7%) | 2/6 (33.3%) | 1/6 (16.7%) |
| Event | Participants Received Acthar |
|---|---|
| HospitalizedRenal and urinary disorders | 1/6 |
| HospitalizationEndocrine disorders | 1/6 |
| DeathGeneral disorders | 1/6 |
| Event | Participants Received Acthar |
|---|---|
| Cramps of hands and fingersMusculoskeletal and connective tissue disorders | 1/6 |
| Dizziness and VertigoNervous system disorders | 1/6 |
| Tightness of ChestCardiac disorders | 1/6 |
| Weight gainMetabolism and nutrition disorders | 1/6 |
| IrritablilityNervous system disorders | 1/6 |
| Moon Face (Swelling of face)Endocrine disorders | 1/6 |
| Elevated Blood PressureVascular disorders | 1/6 |
| Age, Categorical(Participants) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 1 |
| Age, Continuous(Years) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| Mean | 54.5 (33 to 74) |
| Sex: Female, Male(Participants) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| Female | 1 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| United States | 6 |
| eGFR (estimated Glomerular Filtration Rate)(ml/min/1.73 m^2) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| Mean | 49.2 ± 14.6 |
| Serum Creatinine(mg/dl) | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. |
|---|---|
| Mean | 1.75 ± 0.56 |
2 further baseline measures are reported on the registry.
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University of Maryland, Baltimore