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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00270634
First received: December 23, 2005
Last updated: February 11, 2013
Last verified: February 2013
Results First Received: October 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Diseases
Interventions: Drug: Voclosporin
Drug: tacrolimus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 334 de novo renal transplant patients were recruited in 36 US and 4 Canadian transplant centres between January 2006 and December 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
PROMISE was open to adult recipients of a first deceased or living donor renal transplant. Patients with established renal function (as demonstrated by urine output of at least 40 mL/h and a decline of creatinine of at least 15% from baseline during the first 24 h post-transplant) were randomized.

Reporting Groups
  Description
High Dose Voclosporin High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
Mid Dose Voclosporin Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
Low Dose Voclosporin Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
Tacrolimus Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID

Participant Flow:   Overall Study
    High Dose Voclosporin   Mid Dose Voclosporin   Low Dose Voclosporin   Tacrolimus
STARTED   87   77   84   86 
COMPLETED   70   64   62   81 
NOT COMPLETED   17   13   22   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Dose Voclosporin High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
Mid Dose Voclosporin Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
Low Dose Voclosporin Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
Tacrolimus Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
Total Total of all reporting groups

Baseline Measures
   High Dose Voclosporin   Mid Dose Voclosporin   Low Dose Voclosporin   Tacrolimus   Total 
Overall Participants Analyzed 
[Units: Participants]
 87   77   84   86   334 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   82   76   79   82   319 
>=65 years   5   1   5   4   15 
Gender 
[Units: Participants]
         
Female   24   25   33   31   113 
Male   63   52   51   55   221 
Region of Enrollment 
[Units: Participants]
         
United States   74   67   74   75   290 
Canada   13   10   10   11   44 


  Outcome Measures
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1.  Primary:   Biopsy Proven Acute Rejection (BPAR)   [ Time Frame: Six months ]

2.  Secondary:   To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR)   [ Time Frame: Six months ]

3.  Secondary:   The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition   [ Time Frame: Six months ]

4.  Secondary:   Patient Survival   [ Time Frame: Six months ]

5.  Secondary:   Graft Survival   [ Time Frame: Six months ]

6.  Secondary:   Hypertension, Hyperlipidemia, or Hyperglycemia   [ Time Frame: Six months ]

7.  Secondary:   A Composite of Biopsy-proven Chronic Rejection Graft Loss, Death, or Lost to Follow up.   [ Time Frame: Six months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
By limiting access to patients at relatively low risk for rejection and no delayed graft function, the results observed may not be applicable to all renal transplant recipients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Huizinga
Organization: Isotechnika Pharma Inc.
phone: 780 487 1600 ext 223
e-mail: robert.huizinga@isotechnika.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00270634     History of Changes
Other Study ID Numbers: ISA05-01
Study First Received: December 23, 2005
Results First Received: October 10, 2012
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada