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Terminated NCT01436305

Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

Conditions: Kidney Transplantation, Renal Transplantation

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 19
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Location: University of Alabama Birmingham Alabama

Summary

The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage. The researchers also wanted to learn more about the safety of this treatment and long term health of the transplanted kidney.

Eligibility Criteria

Inclusion Criteria: * Male or Female, 18-65 years of age at the time of enrollment; * Ability to understand and provide written informed consent; * Candidate for primary renal allograft from either a living or deceased-donor; * No known contraindications to study therapy using NULOJIX® (belatacept); * Female participants of childbearing potential must have a negative pregnancy test upon study entry; * Female and male participants with reproductive potential must agree to use FDA approved methods of birth control during participation in the study and for 4 months following completion of the study; * Flow-based PRA within last 12 months (in absence of a sensitizing event) of \< 30% as determined by each participating study center. If the subject experienced a sensitizing event after the PRA test date, then the PRA must be repeated and confirmed \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01436305). StuddyBuddy aggregates publicly available trial information.