Brief Summary

This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

Trial Health

On Track

Trial Health Score

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

Enrollment

334

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach

2 countries

45 active sites

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

3.5 years study duration

First Submitted

Initial submission to the registry

December 23, 2005

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed

4 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed

3.6 years until next milestone

Results Posted

Study results publicly available

February 12, 2013

Completed

Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

3.5 years

First QC Date

December 23, 2005

Results QC Date

October 10, 2012

Last Update Submit

February 11, 2013

Conditions

Kidney Diseases

Keywords

Randomized Controlled TrialsImmunosuppressionAdultKidney TransplantationTreatment Outcome

Outcome Measures

Primary Outcomes (1)

Biopsy Proven Acute Rejection (BPAR)
The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.
Six months

Secondary Outcomes (6)

To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR)
Six months
The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition
Six months
Patient Survival
Six months
Graft Survival
Six months
Hypertension, Hyperlipidemia, or Hyperglycemia
Six months
+1 more secondary outcomes

Study Arms (4)

Low Dose Voclosporin

ACTIVE COMPARATOR

Low dose voclosporin

Drug: Voclosporin

Mid Dose Voclosporin

ACTIVE COMPARATOR

Mid Dose Voclosporin

Drug: Voclosporin

High Dose Voclosporin

ACTIVE COMPARATOR

High Dose Voclosporin

Drug: Voclosporin

Tacrolimus

ACTIVE COMPARATOR

Standard Dose Tacrolimus

Drug: tacrolimus

Interventions

VoclosporinDRUG

voclosporin 0.4, 0.6, 0.8 mg/kg po BID

Also known as: ISA247

High Dose VoclosporinLow Dose VoclosporinMid Dose Voclosporin

tacrolimusDRUG

tacrolimus 0.05 mg/kg po BID

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.
Patients must be receiving a first cadaveric or living donor renal transplant.
Patients must be able to receive oral medication at time of randomization.
Females who are not 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 practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.
Able to give written informed consent prior to screening procedures.
Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator.

You may not qualify if:

Receiving a HLA (human leukocyte antigen)identical living related transplant.
Cold ischemic time \> 24 hours.
Peak PRA (panel reactive antibodies) \> 30%
Cadaveric donors who are over age 60, non-heart beating donors, or any cadaveric donors positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
Transplantation of multiple grafts (e.g. kidney and pancreas).
Systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against cytomegalovirus \[CMV\] and/or pneumocystis carinii pneumonia (PCP) infection will be permitted).
Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus. Known negative serology prior to study entry may be used.
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 electrodesiccation.
Requires prohibited medications or treatment during the study.
Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) ≥ 3x upper limit of normal (ULN) at time of transplantation.
White blood cell count ≤ 2.8 x 10\^9/L.
Triglycerides ≥ 3x ULN.
Pregnant women or nursing mothers.
Has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to enrollment.
Previous exposure to voclosporin.
+4 more criteria

Contact the study team to confirm eligibility.