Long-term Follow-up of Spare the Nephron (STN) Patients
Recruitment status was Active, not recruiting
Allograft nephropathy is the most common cause of allograft failure following kidney transplantation. Among putative etiologies, cumulative exposure to calcineurin inhibitors may be one of the important progression factors.
"Spare the Nephron"(STN) is a unique study. Patients were randomized to either continue center-specific Calcinerium Inhibitor (CNI) therapy or have CNI replaced with sirolimus within the first six months after transplantation. Approximately 305 patients were enrolled in the study. More than 230 patients finished 2 years of follow-up. There was better patient and graft survival in those converted to sirolimus. There was also a 10% improvement in the kidney function of those who were converted. In this cohort, we wish to explore the durability of this improvement.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long-term Follow-up of Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients.|
- To compare between treatment groups, change in renal function as measured by 24 hour creatinine clearance and estimated GFR. [ Time Frame: Every 6 months for 3 years. ] [ Designated as safety issue: No ]
- Graft and patient survival. [ Time Frame: Every 6 months for 3 years. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Long term Sirolimus or Tacrolimus
Ths study cohort will consist of participants who successfully completed two years of the original Spare the Nephron (STN) study, a two year prospective multi-center study where participants were assigned to receive either center-specific CNI regimen (assigned at the time of transplantation) or were switched to replace the CNI with Sirolimus therapy.
In this current long-term follow-up study, we will approach patients who previously enrolled in the STN study and offer them the opportunity to enroll to be followed-up for another 3 years. There will be no change in immunosuppression unless clinically indicated. The majority of effort is standard care with every 6 month follow-up appointments.Participants will be required to consent to participate in the three year extension study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01126333
|United States, Maryland|
|University of Maryland Medicine, Division of Adult Nephrology|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Matthew R Weir, MD||University of Maryland|