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Acthar in the treatment of Post-renal transplant recurrent FSGS

University of North Carolina at Chapel Hill


Description

This research study is looking at the use of a drug called H.P. Acthar® Gel (Repository Corticotropin Injection) ("Acthar"). Acthar is currently approved by the Food and Drug Administration for the treatment of infantile spasms in infants and children under 2 years of age and for the treatment of exacerbation (worsening or increase in severity of disease) of multiple sclerosis in adults. Acthar may be used for the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and conditions marked by swelling. Note: Acthar has not been studied specifically in transplant patients. The use of Acthar is thought to be safe as side effects are related to steroids (corticosteroids) which are commonly used in renal transplant patients as part of routine immunosuppression. The purpose of this research study is to find out if the addition of Acthar to the current therapy your doctor is using to manage your FSGS has beneficial effects on transplanted kidney function by decreasing over time the amount of protein being excreted through your kidney.


Keywords:

Kidneys


Category:

Drug or Biologic
Phase:4

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

Adult renal transplant recipients with a diagnosis of recurrent FSGS , or current/previous treatment of recurrent FSGS with no evidence of at least a partial response.


Investigator

Karin True
Clinical Assistant Professor
Medicine-Nephrology

For questions, contact:

Paula Steele
paula_steele@med.unc.edu



Recruitment Period End

September 1, 2020

Location

Primary Location
Clinical & Translation Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA
Secondary Location
Ambulatory Care Center- Kidney Clinic
Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) 3.1.1 Diagnosis of recurrent 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 • Histologic diagnosis of 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 • FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post-transplant • 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. Must be willing to use birthcontrol if woman of child bearing potential or a male with a female partner of child bearing potential.

Not eligible if: More than 2 kidney transplants or other organ transplant. Concurrent infection with HIV, Hep B, Hep C, Parvovirus or systemic fungal infection Malignancy within the last 5 years. • have osteoporosis, scleroderma, ocular herpes simplex (an eye problem), stomach ulcers or a history of ulcers, uncontrolled high blood pressure, tuberculosis, or if you have had a heart attack or stroke in the last 3 months. The study physician will review your medical history to determine other criteria which may be excluded.

Number of Visits

    » 10 In person visit(s)

    Screening, Study Visits: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 52. 24 Hr Urine collection (3) Lab draws at each visit. Acthar injection 2x/week for weeks 1 thru 24. After the first injection you may begin receiving these injections at home when you feel comfortable.

    » 0 Remote visit(s)

Participation Period

52 weeks

Compensation

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.