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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Maryland
ClinicalTrials.gov Identifier:
NCT01126333
First received: May 17, 2010
Last updated: November 21, 2013
Last verified: June 2013
  Purpose

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
Kidney Transplant

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Graft and patient survival. [ Time Frame: Every 6 months for 3 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 305
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)
Groups/Cohorts
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Male or female post-transplant patients who were in the Spare-the-nephron study.
  2. 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.
  3. Women of child bearing potential must not be pregnant or breast-feeding.
  4. 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.
  5. Must pass the evaluation to sign informed consent form.

Exclusion Criteria:

  1. Male or female post-transplant patients who were enrolled in the Spare-the-nephron study, however dropped out during the study period.
  2. Inability to pass the Evaluation to Sign Consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126333

Locations
United States, Maryland
University of Maryland Medicine, Division of Adult Nephrology
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Pfizer
Investigators
Principal Investigator: Matthew R Weir, MD University of Maryland
  More Information

No publications provided

Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT01126333     History of Changes
Other Study ID Numbers: HP-00042739
Study First Received: May 17, 2010
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Nephrotoxicity, Kidney Transplantation, Graft Survival
Kidney transplant survival.

Additional relevant MeSH terms:
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014