NCT01277770

Brief Summary

The purpose of this study is to improve outcome for kidney transplant recipients. There has not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research is necessary to improve transplant outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

10 years

First QC Date

August 19, 2010

Last Update Submit

May 14, 2019

Conditions

Keywords

ThymoglobulinKidney Transplant RecipientsSteroid-FreeImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Data Analysis

    All studies are analyses from the Transplant Outcomes Database. Recipients have signed consent to have medical information entered into the database for these analyses. The database contains information on short, medium and long-term results.

    10 year followup

Study Arms (1)

Kidney Transplant Recipients

Kidney Transplant Recipients at the University of Minnesota since 1984. The study looks at a 10 year followup of steroid-free maintenance immunosuppression, post-transplant infections and evaluation of the DGF nomogram in Thymoglobulin on patients at the University of Minnesota.

Drug: Steroid-Free Maintenance ImmunosuppressionOther: Infection After Kidney TransplantationDrug: Evaluation of the DGF nomogram in Thymoglobulin

Interventions

10 year follow-up of steroid-free maintenance immunosuppression

Also known as: Steroid-Free, Immunosuppression
Kidney Transplant Recipients

A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients).

Also known as: Infection, Transplantation, Steroid-Free
Kidney Transplant Recipients

An evaluation of the DGF nomogram in Thymoglobulin treated recipients at the University of Minnesota

Also known as: Thymoglobulin
Kidney Transplant Recipients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney transplant recipients at the University of Minnesota

You may qualify if:

  • Kidney Transplant Recipient at the University of Minnesota
  • Kidney Transplant Recipients on steroid-free maintenance immunosuppression

You may not qualify if:

  • Non-kidney transplant patients at the University of Minnesota

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Interventions

Immunosuppression TherapyTransplantationthymoglobulin

Intervention Hierarchy (Ancestors)

ImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesSurgical Procedures, Operative

Study Officials

  • Arthur Matas, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2010

First Posted

January 17, 2011

Study Start

May 1, 2009

Primary Completion

May 6, 2019

Study Completion

May 6, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations