Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006178
First received: August 15, 2000
Last updated: June 16, 2010
Last verified: June 2010
Results First Received: January 14, 2010  
Study Type: Interventional
Study Design: Primary Purpose: Treatment
Condition: Kidney Failure
Interventions: Drug: Sirolimus
Drug: Thymoglobulin

  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
No text entered.

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
Sirolimus Monotherapy No text entered.

Participant Flow:   Overall Study
    Sirolimus Monotherapy  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  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
Sirolimus Monotherapy No text entered.

Baseline Measures
    Sirolimus Monotherapy  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.0  ± 12.7  
Gender  
[units: participants]
 
Female     4  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   Serum Creatinine Concentration   [ Time Frame: 6 months after intervention ]

2.  Primary:   Serum Creatinine Concentration   [ Time Frame: 12 months after intervention ]

3.  Secondary:   Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)   [ Time Frame: 6 month after intervention ]

4.  Secondary:   Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)   [ Time Frame: 12 months after intervention ]


  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
Optimal dose of RATG remains to be determined. Whether other depleting agents are as effective as RATG is unclear.


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


Results Point of Contact:  
Name/Title: Dr. Allan D. Kirk
Organization: National Institutes of Health
phone: N/A
e-mail: allank@intra.niddk.nih.gov


Publications:

Responsible Party: Monique E. Cho, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00006178     History of Changes
Other Study ID Numbers: 000196, 00-DK-0196
Study First Received: August 15, 2000
Results First Received: January 14, 2010
Last Updated: June 16, 2010
Health Authority: United States: Federal Government