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Slow Enrollment
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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acthar | Experimental | The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar gel | Drug | Administration of the study drug in addition to the current maintenance immunosuppressive agents |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Outcome | composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdolreza Haririan, MD, MPH | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama School of Medicine, Alabama Transplant Center | Birmingham | Alabama | 35294 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Acthar | The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chronic antibody-mediated rejection (AMR). Acthar gel: Administration of the study drug in addition to the current maintenance immunosuppressive agents |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. | In this cohort Acthar gel will be administered to all the enrolled patient with chronic AMR. There is a single arm in this study. Acthar gel: Administration of the study drug in addition to the current maintenance immunosuppressive agents |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants were monitored for adverse events throughout their participation. | Posted | Count of Participants | Participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Received Acthar | All participants in the study received Acthar. | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cramps of hands and fingers | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Only one participant completed the treatment with the study drug Acthar (24 weeks). The other five (5) individuals withdrew from the study early, therefore we are not able to analyze/interpret the efficacy of the study drug.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A Haririan | University of MAryland sSchool of Medicine | 410-328-5720 | ahariria@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2016 | Aug 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Unniversity of Maryland Medical Center |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| eGFR (estimated Glomerular Filtration Rate) | Mean | Standard Deviation | ml/min/1.73 m^2 |
|
| Serum Creatinine | Mean | Standard Deviation | mg/dl |
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| Urine Albumin | Mean | Standard Deviation | mg/L |
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| Urine Albumin Creatinine Ratio | Mean | Standard Deviation | mg/g Creatinine |
|
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| Secondary | Efficacy Outcome | composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria | Study participants who received the study drug | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 6 |
| 2 |
| 6 |
| 1 |
| 6 |
| Hospitalization | Endocrine disorders | Non-systematic Assessment | New onset diabetes |
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| Death | General disorders | Non-systematic Assessment | Participant withdrew from the study due to general debility. He was found down (fallen)at home, medics pronounced him deceased, per report from spouse. |
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| Dizziness and Vertigo | Nervous system disorders | Non-systematic Assessment |
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| Tightness of Chest | Cardiac disorders | Non-systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Irritablility | Nervous system disorders | Non-systematic Assessment |
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| Moon Face (Swelling of face) | Endocrine disorders | Non-systematic Assessment |
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| Elevated Blood Pressure | Vascular disorders | Non-systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Increased proteinuria |
|