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Study of ISA247 in De Novo Renal Transplantation (PROMISE)
This study is ongoing, but not recruiting participants.
Sponsored by: Isotechnika
Information provided by: Isotechnika
ClinicalTrials.gov Identifier: NCT00270634
  Purpose

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


Condition Intervention Phase
Kidney Diseases
Drug: Voclosporin
Drug: tacrolimus
Phase II

MedlinePlus related topics: Kidney Transplantation
Drug Information available for: Tacrolimus Tacrolimus anhydrous
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase IIb, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in De Novo Renal Transplant Patients

Further study details as provided by Isotechnika:

Primary Outcome Measures:
  • Biopsy proven acute rejection (BPAR) [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate a 5% improvement in renal function as measured by Iothalamate glomerular filtration rate (GFR) [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic-pharmacodynamic relationship between ISA247 and calcineurin inhibition, or tacrolimus and calcineurin inhibition [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • To determine patient survival [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • To determine graft survival [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • To determine the proportion of patients with hypertension, hyperlipidemia, or hyperglycemia [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • A composite of biopsy-proven chronic rejection graft loss, death, or lost to follow up. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • A composite of biopsy-proven acute rejections, graft loss or death [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • To establish the safety of voclosporin [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Enrollment: 334
Study Start Date: January 2006
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Voclosporin
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
2: Active Comparator Drug: Voclosporin
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
3: Active Comparator Drug: Voclosporin
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
4: Active Comparator Drug: tacrolimus
tacrolimus 0.05 mg/kg po BID

Detailed Description:

Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus. Voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection.

Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Receiving a HLA 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.
  • A history of active alcoholism or drug addiction within 1 year prior to study entry.
  • Weighs < 45 kg (99 lbs) or > 140 kg (308 lbs).
  • A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the investigator.
  • Allergy to iodine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270634

  Show 45 Study Locations
Sponsors and Collaborators
Isotechnika
Investigators
Study Director: Daniel Abramowicz, MD, PhD Erasme Hospital
Study Director: Philip Belitsky, MD No Affiliation
Study Director: Arthur Matas, MD University of Minnesota
Study Director: Mark Pescovitz, MD Indiana University
Study Director: A. Osama Gaber, MD The Methodist Hospital System
Study Director: Flavio Vincenti, MD Skin Care Center
  More Information

Publications:
Responsible Party: Isotechnika ( Robert Huizinga )
Study ID Numbers: ISA05-01
Study First Received: December 23, 2005
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00270634  
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Isotechnika:
Randomized Controlled Trials
Immunosuppression
Adult
Kidney Transplantation
Treatment Outcome

Study placed in the following topic categories:
Urologic Diseases
Tacrolimus
Kidney Diseases

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009