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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126333
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : May 8, 2017
Information provided by (Responsible Party):
Matthew Weir, University of Maryland

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.

Condition or disease
Kidney Transplant

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 128 participants
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.
Study Start Date : June 2010
Actual Primary Completion Date : June 30, 2014
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

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.

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Graft and patient survival. [ Time Frame: Every 6 months for 3 years. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney transplant recipients who were previously enrolled in the Spare-the-nephron study.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01126333

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

Responsible Party: Matthew Weir, PI, University of Maryland Identifier: NCT01126333     History of Changes
Other Study ID Numbers: HP-00042739
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents