Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation
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|ClinicalTrials.gov Identifier: NCT02683889|
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : December 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|FSGS||Drug: Acthar||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: One arm
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.
patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
- Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria [ Time Frame: 2 years ]This will be studied in the renal transplant biopsies
- Rate of recurrence of proteinuria [ Time Frame: 2 years ]By measurement of urine protein and urine creatinine ratio
- renal function after transplantation [ Time Frame: 1 year ]By measurement of the estimated glomerular filtration rate with patient's creatinine
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): NCT02683889
|Contact: Monica Grafals, MD, MPH||720 848 2237||MONICA.GRAFALS@CUANSCHUTZ.EDU|
|United States, District of Columbia|
|Medstar Georgetown Transplant Institute||Recruiting|
|Washington, District of Columbia, United States, 20005|
|Contact: Monica Grafals, MD, MPH 202-444-3700|
|Principal Investigator:||Monica B Grafals, MD, MPH||University of Colorado, Denver|