Long-term Follow-up of Spare the Nephron (STN) Patients (STN)
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|ClinicalTrials.gov Identifier: NCT01126333|
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : May 8, 2017
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||128 participants|
|Official Title:||Long-term Follow-up of Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients.|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 30, 2014|
|Actual Study Completion Date :||June 30, 2015|
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.
- 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. ]
- Graft and patient survival. [ Time Frame: Every 6 months for 3 years. ]
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): 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|