Clinical Trials Logo
  1. Home
  2. Kidney Diseases
  3. NCT00270634

Study of ISA247 (Voclosporin) in De Novo Renal Transplantation — PROMISE  

Kidney Diseases Clinical Trial

Official title:
A Phase IIb, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 (Voclosporin) and Tacrolimus (Prograf®) in De Novo Renal Transplant Patients

Clinical Trial Summary

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

Clinical Trial Description

Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After Transplant (NODAT). 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00270634
Study type Interventional
Source Aurinia Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 2
Start date January 2006
Completion date July 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Completed NCT03545113 - Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease N/A
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Recruiting NCT04559321 - Holmium Vs Trilogy Kidney Stones GUY's 1-2 Phase 3
Recruiting NCT05036850 - China Kidney Patient Trials Network
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01679587 - Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD) Phase 1
Completed NCT01155141 - Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH Phase 4
Completed NCT00755690 - Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease N/A
Recruiting NCT05759754 - Effects of Traditional Chinese Medicine (GSJYF) in Children With Inherited Proteinuric Kidney Disease N/A
Completed NCT03213158 - Ixazomib for Desensitization Phase 2
Active, not recruiting NCT02237352 - Mechanisms of Diabetic Nephropathy in Ecuador
Recruiting NCT06067867 - Kidney and Pregnancy Registry
Recruiting NCT04110080 - Enhanced Recovery After Surgery in Kidney Transplant Donors N/A
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Enrolling by invitation NCT05324878 - Honoring Individual Goals and Hopes: Implementing Advance Care Planning for Persons With Kidney Disease on Dialysis
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Active, not recruiting NCT04631965 - Healthcare Transition of Adolescents With Chronic Health Conditions
Completed NCT03394859 - Electronic Medical Records and Genomics (eMERGE) Phase III