Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation (INSPIRE)

January 16, 2014 updated by: Aurinia Pharmaceuticals Inc.

A Phase III, Randomized, Multicentre, Open-Label, Concentration-Controlled, Safety and Efficacy Study of Voclosporin and Tacrolimus in Renal Transplantation

The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This will be a phase III, randomized, multicentre, open-label, concentration-controlled study in subjects undergoing a first or second renal transplant, with induction immunosuppression with an IL-2 receptor antibody (basiliximab), mycophenolate mofetil and steroids.

The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females aged 18-65 years inclusive at the time of screening.
  • Recipients of a first or second deceased donor or living donor renal transplant.

Exclusion Criteria:

  • Subjects presently receiving immunosuppression for a previously failed transplant.
  • Females who are pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication.
  • Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are not practicing a highly effective method of birth control.
  • Subjects receiving a HLA identical living related transplant.
  • Subjects wth a positive T-cell lymphocytotoxic cross match, or positive flow T and B cell cross match.
  • Subjects undergoing primary transplant with a current PRA (or CPRA) ≥ 25%.
  • Subjects who experienced graft loss within 1 year of transplant.
  • Subjects receiving a kidney from a ABO incompatible donor.
  • Subjects receiving a kidney from a deceased donor positive for HIV, HBV, HCV or tuberculosis.
  • Subjects receiving a a kidney from a non-heart beating donor.
  • Subjects receiving paired (en bloc or paired) kidney transplants.
  • Transplantation of multiple grafts (e.g. kidney and pancreas).
  • Subjects receiving a kidney with a cold ischemia time > 30 hours.
  • Subjects receiving any transplanted organ other than a kidney.
  • Recipients of a bone marrow or stem cell transplant.
  • Any systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against CMV and/or PCP infection will be permitted).
  • Subjects with positive results of the following serological tests: HIV I Ab, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and the anti-hepatitis C virus antibody (HCV Ab). Negative results for these serological tests must be documented within 12 months prior to randomization.
  • Subjects with active tuberculosis (Tb) requiring treatment within the last 3 years. Subjects with a known positive purified protein derivative (PPD) test are not eligible unless they have completed treatment for latent Tb and have a negative chest X-ray at time of enrollment. PPD testing must have been done within the last 12 months, and a positive result is defined as ≥ 10 mm induration, a Heaf score of >1 in non-Bacille Calmette-Guérin (BCG) immunized subjects, or >2 in BCG immunized subjects.
  • Subjects with a current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodessication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Voclosporin
Drug: voclosporin
Initial dose of voclosporin 0.8 mg/kg BID, then concentration controlled
Other Names:
  • voclosporin, ISA247
Active Comparator: Tacrolimus
Drug: tacrolimus
tacrolimus as per labeled dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.
Time Frame: 1 Year post-Transplant
FDA Efficacy Failure is biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist) where subjects who experience death, graft loss (return to dialysis for >30 days, allograft nephrectomy or re-transplantation), or lost to follow-up are included in the analysis as treatment failures. EMA Efficacy Failure includes any subject experiencing any of the following: biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1A as determined by the central pathologist), death, graft loss or graft dysfunction (Cockcroft-Gault CrCl < 40 mL/min).
1 Year post-Transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurinia Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISA10-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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