FSGSPhase 3NCT02683889
Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation
A Phase 3 study testing Acthar in people with FSGS, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- FSGS
- What is being tested?
- Acthar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 10 Jun 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FSGS
- To receive either a live donor or deceased donor kidney transplant
Who cannot join
- Not having FSGS
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Georgetown Transplant Institute
Washington D.C., District of Columbia, 20005
About this study
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
This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.
Read the 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.
- Conditions
- FSGS
- Being tested
- Acthar
- Keywords
- Kidney transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActharDrug
patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Acthar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria
This will be studied in the renal transplant biopsies
Measured: 2 years
Rate of Recurrence of Proteinuria
By measurement of urine protein and urine creatinine ratio
Measured: 2 years
Secondary outcomes (1)
Renal Function After Transplantation
By measurement of the estimated glomerular filtration rate with patient's creatinine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start1 Feb 2019
- Primary completion6 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FSGSStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sixto Giusti, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683889
- Sponsor's protocol ID
- 17-2336
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2016
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No