NCT01586845

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Typical duration for phase_3

Status
withdrawn

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

First Submitted

Initial submission to the registry

April 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

April 25, 2012

Last Update Submit

January 16, 2014

Conditions

Renal Transplantation

Keywords

Randomized Controlled TrialsImmunosuppressionAdultKidney TransplantationTreatment Outcome

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (2)

Voclosporin

EXPERIMENTAL

Voclosporin

Drug: voclosporin

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus

Drug: tacrolimus

Interventions

voclosporinDRUG

Initial dose of voclosporin 0.8 mg/kg BID, then concentration controlled

Also known as: voclosporin, ISA247
Voclosporin
tacrolimusDRUG

tacrolimus as per labeled dose

Tacrolimus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.

    PMID: 21943027BACKGROUND

  • Kuglstatter A, Mueller F, Kusznir E, Gsell B, Stihle M, Thoma R, Benz J, Aspeslet L, Freitag D, Hennig M. Structural basis for the cyclophilin A binding affinity and immunosuppressive potency of E-ISA247 (voclosporin). Acta Crystallogr D Biol Crystallogr. 2011 Feb;67(Pt 2):119-23. doi: 10.1107/S0907444910051905. Epub 2011 Jan 15.

    PMID: 21245533BACKGROUND

  • Birsan T, Dambrin C, Freitag DG, Yatscoff RW, Morris RE. The novel calcineurin inhibitor ISA247: a more potent immunosuppressant than cyclosporine in vitro. Transpl Int. 2005 May;17(12):767-71. doi: 10.1007/s00147-004-0799-z. Epub 2005 Apr 13.

    PMID: 15827754BACKGROUND

MeSH Terms

Interventions

voclosporinTacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 27, 2012

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 20, 2014

Record last verified: 2014-01