Phase 2
Completed N=334
Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
Source: ClinicalTrials.gov NCT00270634 ↗Enrolled (actual)
334
Serious AEs
44.3%
Results posted
Feb 2013
Primary outcomePrimary: Biopsy Proven Acute Rejection (BPAR) — 2.3; 9.1; 10.7; 5.8 percentage of participants
Summary
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biopsy Proven Acute Rejection (BPAR) |
2.3; 9.1; 10.7; 5.8 | — |
| SECONDARY To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR) |
68; 72; 71; 69 | — |
| SECONDARY The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition |
57.3; 47.5; 38.8; 23.0 | — |
| SECONDARY Patient Survival |
98.9; 100; 100; 97.7 | — |
| SECONDARY Graft Survival |
98.9; 100; 100; 97.7 | — |
| SECONDARY Hypertension, Hyperlipidemia, or Hyperglycemia |
96.6; 97.4; 96.4; 95.3; 28; 30 | — |
| SECONDARY A Composite of Biopsy-proven Chronic Rejection Graft Loss, Death, or Lost to Follow up. |
5.6; 7.4; 3.7; 3.9 | — |
Eligibility 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 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 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.
Data sourced from ClinicalTrials.gov (NCT00270634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.