Ignite Creation Date:
2024-05-06 @ 7:31 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02546492
Status:
TERMINATED
Last Update Posted:
2022-10-06
First Post:
2015-04-10
Brief Title:
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TGActhar
Brief Summary:
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 gKg andor Rituximab in patients with chronic antibody-mediated rejection CAMR
Detailed Description:
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 mofetilSodium and prednisone
After screening for the inclusionexclusion 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 CNIsirolimus drug level according to the centers 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
After screening for the inclusionexclusion 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 CNIsirolimus drug level according to the centers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None