Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

Study Overview
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Brief Summary
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This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

Detailed Description
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This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS. Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria. Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients. By the current data, FSGS should recur in 23% of patients. Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation. Screening will be performed by the Principal Investigator during the kidney transplant evaluation clinics and during the wait list kidney transplant evaluation clinic. All patients with FSGS will have maintenance immunosuppression with belatacept (if EBV positive), prograf, cellcept and prednisone. If after one year the patient has been stable and there has not been rejection, will stop the prograf and continue solely with belatacept, cellcept and prednisone. Dosage and Administration of Acthar The dose of acthar to be given to every enrolled patient will be 80 units twice a week for 6 months.

Official Title
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The Use of Acthar (ACTH) in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and Are Undergoing a Renal Transplant

Conditions
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FSGS

Intervention / Treatment
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* Drug: Acthar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FSGS To receive either a live donor or deceased donor kidney transplant Exclusion Criteria: Not having FSGS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One arm<br>One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants. | Drug: Acthar<br>* patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria | This will be studied in the renal transplant biopsies | 2 years | 
| Rate of recurrence of proteinuria | By measurement of urine protein and urine creatinine ratio | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function after transplantation | By measurement of the estimated glomerular filtration rate with patient's creatinine | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplant