FSGS
Conditions
Keywords
Kidney transplant
Brief summary
This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.
Detailed description
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.
Interventions
DRUGActhar
patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* FSGS * To receive either a live donor or deceased donor kidney transplant
Exclusion criteria
* Not having FSGS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria | 2 years | This will be studied in the renal transplant biopsies |
| Rate of Recurrence of Proteinuria | 2 years | By measurement of urine protein and urine creatinine ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function After Transplantation | 1 year | By measurement of the estimated glomerular filtration rate with patient's creatinine |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSixto Giusti, MD
University of Colorado, Denver
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 43.36 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
None listed