Long-term Follow-up of Spare the Nephron (STN) Patients

NCT01126333 | Completed

• 1 other identifier: HP-00042739
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant

Keywords

Nephrotoxicity, Kidney Transplantation, Graft Survival; Kidney transplant survival.

Outcome Measures

Primary Outcomes (1)

• To compare between treatment groups, change in renal function as measured by 24 hour creatinine clearance and estimated GFR.

  Every 6 months for 3 years.

Secondary Outcomes (1)

• Graft and patient survival.

  Every 6 months for 3 years.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients who were previously enrolled in the Spare-the-nephron study.

You may qualify if:

• Male or female post-transplant patients who were in the Spare-the-nephron study.
• Patients capable of understanding the purpose and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
• Women of child bearing potential must not be pregnant or breast-feeding.
• Women of child bearing age must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy or hysterectomy. Effective contraception must be used before beginning of study drug therapy, for duration of study and for 12 weeks following the completion of study.
• Must pass the evaluation to sign informed consent form.

You may not qualify if:

• Male or female post-transplant patients who were enrolled in the Spare-the-nephron study, however dropped out during the study period.
• Inability to pass the Evaluation to Sign Consent.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Pfizer: collaborator

Study Sites (1)

University of Maryland Medicine, Division of Adult Nephrology

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Matthew R Weir, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: June 1, 2010
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2015
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (1)