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Tacrolimus to Sirolimus Conversion for Delayed Graft Function (RAPA)

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ClinicalTrials.gov Identifier: NCT00931255
Recruitment Status : Terminated (The trial was stopped because of slow recruitment.)
First Posted : July 2, 2009
Results First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Abdoleza Haririan, University of Maryland

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Kidney Transplant
Delayed Graft Function
Interventions: Drug: Tacrolimus
Drug: Sirolimus

  Participant Flow

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
Tacrolimus

Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.

Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol

Sirolimus

5 mg, PO , daily

Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol


Participant Flow:   Overall Study
    Tacrolimus   Sirolimus
STARTED   17   15 
COMPLETED   15   12 
NOT COMPLETED   2   3 
Follow up biopsy not done                2                3 



  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
Tacrolimus

Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.

Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol

Sirolimus

5 mg, PO , daily

Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol

Total Total of all reporting groups

Baseline Measures
   Tacrolimus   Sirolimus   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   15   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.4  (9.7)   49.9  (10.1)   51.7  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  23.5%      5  33.3%      9  28.1% 
Male      13  76.5%      10  66.7%      23  71.9% 


  Outcome Measures

1.  Primary:   The Composite Endpoint of Reduction of e eGFR at One Year by More Than 15% & the Progression in Fibrosis Score at One Year by >=20% Compared With the Baseline Values   [ Time Frame: One year ]

2.  Secondary:   eGFR   [ Time Frame: One year ]

3.  Secondary:   Change in eGFR From Baseline to 1-year   [ Time Frame: 1 year ]

4.  Secondary:   Graft Survival (Actual, Actuarial)   [ Time Frame: 1 year ]

5.  Secondary:   Incidence of Acute Rejection (Actual, Actuarial)   [ Time Frame: 1 year ]

6.  Secondary:   Incidence of BK Nephropathy (Cumulative)   [ Time Frame: 1 year ]

7.  Secondary:   Change in Inflammatory Marker : CRP From Baseline   [ Time Frame: 1 year ]

8.  Secondary:   Change in Inflammatory Marker, IL-6 From Baseline   [ Time Frame: 1 Year ]

9.  Secondary:   Change in Inflammatory Marker, MCP, From Baseline   [ Time Frame: 1 year ]


  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
The trial was stopped because of slow enrollment. Hence, the target enrollment number was not achieved.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Abdolreza Haririan, MD
Organization: UMaryland
phone: 410-328-5720
e-mail: ahariria@medicine.umaryland.edu



Responsible Party: Abdoleza Haririan, University of Maryland
ClinicalTrials.gov Identifier: NCT00931255     History of Changes
Other Study ID Numbers: HP-00042201
First Submitted: June 29, 2009
First Posted: July 2, 2009
Results First Submitted: December 31, 2014
Results First Posted: March 16, 2018
Last Update Posted: March 16, 2018