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Trial record 36 of 66 for:    "Viral Infectious Disease" | "Mycophenolic acid"

Using mTOR Inhibitors in the Prevention of BK Nephropathy

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ClinicalTrials.gov Identifier: NCT01649609
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborators:
Pfizer
Cornell University
Information provided by (Responsible Party):
Sumit Mohan, MD, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions BK Viremia
BK Nephropathy
Interventions Drug: Tacrolimus
Drug: Mycophenolate acid
Drug: Sirolimus
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Immunosuppression Reduction Arm mTOR Substitution Arm
Hide Arm/Group Description Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL). Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Standard Immunosuppression Reduction Arm mTOR Substitution Arm Total
Hide Arm/Group Description Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL). Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL). Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  50.0%
18
  90.0%
28
  70.0%
>=65 years
10
  50.0%
2
  10.0%
12
  30.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
61.04  (14.12) 52.39  (12.69) 56.7  (13.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
6
  30.0%
8
  40.0%
14
  35.0%
Male
14
  70.0%
12
  60.0%
26
  65.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
4
  20.0%
1
   5.0%
5
  12.5%
Not Hispanic or Latino
15
  75.0%
18
  90.0%
33
  82.5%
Unknown or Not Reported
1
   5.0%
1
   5.0%
2
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
1
   5.0%
0
   0.0%
1
   2.5%
Asian
4
  20.0%
4
  20.0%
8
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   5.0%
1
   2.5%
Black or African American
3
  15.0%
6
  30.0%
9
  22.5%
White
10
  50.0%
8
  40.0%
18
  45.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  10.0%
1
   5.0%
3
   7.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
Delayed Graft Function  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
8
  40.0%
8
  40.0%
16
  40.0%
1.Primary Outcome
Title Number of Participants With BK Viral Load <600 Copies/mL
Hide Description A Viral load of <600 copies/mL for at least 3 months indicates sustained clearance of BK viremia, confirmed by blood test
Time Frame Up to 12 months from enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Immunosuppression Reduction Arm mTOR Substitution Arm
Hide Arm/Group Description:
Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
13
  65.0%
17
  85.0%
2.Secondary Outcome
Title Number of Participants With Incidence of BK Nephropathy
Hide Description The number of people with incidence of BK Nephropathy in each of the two Arms
Time Frame Up to 24 months from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Immunosuppression Reduction Arm mTOR Substitution Arm
Hide Arm/Group Description:
Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL).
Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.0%
1
   5.0%
Time Frame Up to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Immunosuppression Reduction Arm mTOR Substitution Arm
Hide Arm/Group Description Those in the standard immunosuppression reduction arm experienced a reduction of the calcineurin inhibitor (i.e. tacrolimus) dosage to a goal level of 4-8 μg/L and reduction of the antimetabolite agent (mycophenolic acid/mycophenolate mofetil) to 50% of dose at the time of detection of viremia (once BK viremia PCR >5000 copies/mL). Those in the mTOR substitution arm experienced replacement of the calcineurin inhibitor (i.e. tacrolimus) with the mTOR agent, Sirolimus for a level of 6-10 μg/L coupled with reduction of the antimetabolite dose to 50% of the dose at the time of detection of the viremia (once BK viremia PCR >5000 copies/mL).
All-Cause Mortality
Standard Immunosuppression Reduction Arm mTOR Substitution Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Immunosuppression Reduction Arm mTOR Substitution Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      1/20 (5.00%)    
Renal and urinary disorders     
Proteinuria  [1]  1/20 (5.00%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Rapa Pneumonitis  [2]  0/20 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
Proteinuria > 1 gram
[2]
Pneumonitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Immunosuppression Reduction Arm mTOR Substitution Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sumit Mohan, MD
Organization: Columbia University Medical Center
Phone: 2123053273
EMail: sm2206@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Sumit Mohan, MD, Columbia University
ClinicalTrials.gov Identifier: NCT01649609     History of Changes
Other Study ID Numbers: AAAI9004
WS2036051 ( Other Identifier: Pfizer )
First Submitted: July 23, 2012
First Posted: July 25, 2012
Results First Submitted: January 31, 2018
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018