Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Isotechnika |
---|---|
Information provided by: | Isotechnika |
ClinicalTrials.gov Identifier: | NCT00270634 |
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 |
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 |
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
|
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Randomized Controlled Trials Immunosuppression Adult Kidney Transplantation Treatment Outcome |
Urologic Diseases Tacrolimus Kidney Diseases |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |