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Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

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ClinicalTrials.gov Identifier: NCT00275509
Recruitment Status : Completed
First Posted : January 12, 2006
Results First Posted : December 20, 2017
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Kidney Failure, Chronic
Interventions: Drug: Thymoglobulin
Drug: Daclizumab
Other: Plasmapheresis
Drug: Mycophenolate mofetil
Drug: Tacrolimus
Drug: Dexamethasone
Drug: Prednisone
Drug: Cytogam

  Participant Flow

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 207 participant were assessed for eligibility. Excluded (n=151) Not meeting inclusion criteria (n=115) Declined to participate (n=2) Did not reach transplant prior to end of study (n=34). A total of 56 were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Thymoglobulin Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6.
Daclizumab Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).

Participant Flow:   Overall Study
    Thymoglobulin   Daclizumab
STARTED   30   26 
COMPLETED   30   25 
NOT COMPLETED   0   1 
graft thrombosis, post-operative day #8                0                1 



  Baseline Characteristics

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
Tymoglobulin Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
Daclizumab Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
Total Total of all reporting groups

Baseline Measures
   Tymoglobulin   Daclizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   26   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.2  (10.6)   46.5  (15.4)   47.4  (13.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19  63.3%      19  73.1%      38  67.9% 
Male      11  36.7%      7  26.9%      18  32.1% 
Region of Enrollment 
[Units: Participants]
     
United States   30   26   56 


  Outcome Measures

1.  Primary:   6-month Acute Cellular-mediated Rejection Rate (CMR)   [ Time Frame: Up to 6 months ]

2.  Primary:   6-month Acute Antibody-mediated Rejection Rate (AMR)   [ Time Frame: Up to 6 months ]

3.  Primary:   6-month Cumulative Rejection Incidence (Either CMR, AMR or Both)   [ Time Frame: Up to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Montgomery, MD
Organization: New York University Langone Transplant Institute
phone: 646-501-2418
e-mail: Robert.Montgomery@nyumc.org


Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00275509     History of Changes
Other Study ID Numbers: IRB00078055
First Submitted: January 10, 2006
First Posted: January 12, 2006
Results First Submitted: November 20, 2017
Results First Posted: December 20, 2017
Last Update Posted: January 18, 2018