ClinicalTrials.gov
ClinicalTrials.gov Menu

Acthar for Treatment of Post-transplant FSGS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02399462
Recruitment Status : Not yet recruiting
First Posted : March 26, 2015
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This is an open label safety and feasibility trial using Acthar® in addition to center-specific standard therapy including plasma exchange, for treatment of post transplant recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects will receive Acthar® 40 units subcutaneously (SC) twice weekly for two weeks then 80 units SC twice weekly for 24 weeks.

Condition or disease Intervention/treatment Phase
FSGS Renal Transplantation Kidney Transplantation Drug: Acthar Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acthar for Treatment of Post-transplant FSGS
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Drug Arm
Acthar SC injections
Drug: Acthar

Agent Dose Route Schedule H.P. Acthar Gel 40 units SC Twice weekly* Weeks 1 and 2

H.P. Acthar Gel 80 units SC Twice weekly* Weeks 3 through 24

H.P. Acthar Gel 80 units SC ONCE weekly* Weeks 25 through 26

H.P. Acthar Gel 40 units SC ONCE weekly* Weeks 27 through 28

*Injections are to be spaced 72-96 hours apart (+/-6 hours).

Other Name: ACTH (adrenocorticotropic hormone ), corticotropin




Primary Outcome Measures :
  1. number of patients with proteinuria [ Time Frame: 24 and 52 weeks ]
    partial and complete remission of proteinuria


Secondary Outcome Measures :
  1. Graft loss [ Time Frame: during study period ]
    graft loss defined by return to dialysis, re-transplant or death during study period

  2. eGFR change [ Time Frame: weeks 4,8,12,16,20 and 24 ]
    estimated Glomerular filtration rate (eGFR MDRD formula) change from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Proteinuria > 1 g/d by urine protein/creatinine ratio (UP/C) or 24 hour urine collection
  • If treated with an angiotensin-converting-enzyme inhibitor (ACEi) or Angiotensin II receptor blockers (ARB), must be on a stable dose for at least 2 weeks prior to enrollment
  • Newly diagnosed recurrent focal and segmental glomerulosclerosis (FSGS), or current/previous treatment of recurrent FSGS with no evidence of at least a partial response as defined by one or more of the following:

    1. Recurrent FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), with FSGS as the primary disease confirmed by native renal biopsy prior to transplant
    2. FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post transplant
    3. Patients at any time period post transplant with an established diagnosis of recurrent FSGS in the first 18 months post transplant who did not respond to conventional therapy as defined by persistent proteinuria of > 3 g/d by UP/C or 24 hour urine collection

Exclusion Criteria:

  • Lactation, pregnancy or refusal of birth control in women of childbearing potential
  • Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or parvovirus B-19
  • Malignancy (with the exception of treated and cured basal cell or squamous cell carcinoma)
  • Evidence of diabetic nephropathy, transplant glomerulopathy or other pathologies that could be associated with secondary FSGS on renal transplant biopsy
  • Non-renal organ transplant (with the exception of pancreas transplant)
  • Contraindication to receiving Acthar®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399462


Contacts
Contact: Karin True, MD 919-445-2687 karin_true@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Karin True, MD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02399462     History of Changes
Other Study ID Numbers: 15-0999
ACTH-101 ( Other Identifier: UNC )
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action