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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar | Drug | patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function After Transplantation | By measurement of the estimated glomerular filtration rate with patient's creatinine | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sixto Giusti, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Georgetown Transplant Institute | Washington D.C. | District of Columbia | 20005 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS. A total of 15 subjects where enrolled. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria | This will be studied in the renal transplant biopsies | Posted | Count of Participants | Participants | 2 years |
|
|
30 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemia | Endocrine disorders | Non-systematic Assessment | Severe hypoglycemia secondary to heavy alcohol use following transplant. Event occurred immediately following addition of glipizide and had a blood glucose of 10 on presentation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anuria | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Director of Transplant Clinical Research | University of Colorado Denver Anschutz Medical Campus | 3037246446 | ivan.2.rodriguez@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol and statistical analysis plan | Jul 11, 2018 | Jan 29, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Rate of Recurrence of Proteinuria | By measurement of urine protein and urine creatinine ratio | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Renal Function After Transplantation | By measurement of the estimated glomerular filtration rate with patient's creatinine | Not Posted | Apr 2026 | 1 year | Participants |
| 0 |
| 15 |
| 1 |
| 15 |
| 1 |
| 15 |
|
| Acute Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Delayed Graft Function | Renal and urinary disorders | Non-systematic Assessment |
|
| CMV Viremia | Infections and infestations | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |