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

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.

Conditions

• Kidney Transplantation
• Renal Transplantation

Interventions

DRUG

Alemtuzumab

Induction therapy. Group 1 and 2 study therapy regimens include induction with alemtuzumab, administered as a single intravenous dose intra-operatively over a period of 2 hours.

DRUG

MMF

All treatment groups (e.g., Group 1, 2 and 3): Administered at a target dose of 1000 mg by mouth twice daily beginning on the day of surgery or post operative day 1 and adjusted as clinically warranted. Note: Myfortic® (mycophenolate sodium) may be used as a replacement for MMF, at a dose of 720 mg taken by mouth twice daily.

BIOLOGICAL

Basiliximab

Induction therapy. Group 3 study therapy regimen includes induction with basiliximab, administered in two doses: 1 dose administered within 2 hours prior to transplantation surgery and the 2nd dose 4 days after transplantation (unless held due to contraindication\[s\])

DRUG

Short-term Tac

Short-term (3 months)

DRUG

tacrolimus

maintenance

BIOLOGICAL

Belatacept

maintenance

DRUG

methylprednisolone

All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.

Sponsors & Collaborators

• Clinical Trials in Organ Transplantation

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Kenneth Newell, MD, PhD · Emory University

• Christian P. Larsen, MD, DPhil · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2015-04-30

Completion

2015-04-30

Countries

• United States

Study Locations