Trial Outcomes & Findings for Using mTOR Inhibitors in the Prevention of BK Nephropathy (NCT NCT01649609)

NCT ID: NCT01649609

Last Updated: 2018-02-28

Results Overview

A Viral load of \<600 copies/mL for at least 3 months indicates sustained clearance of BK viremia, confirmed by blood test

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Up to 12 months from enrollment
• Results posted on: 2018-02-28

Participant Flow

Participant milestones

Measure	Standard Immunosuppression Reduction Arm 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).	mTOR Substitution Arm 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 Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using mTOR Inhibitors in the Prevention of BK Nephropathy

Baseline characteristics by cohort

Measure	Standard Immunosuppression Reduction Arm n=20 Participants 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).	mTOR Substitution Arm n=20 Participants 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 n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	61.04 Years STANDARD_DEVIATION 14.12 • n=5 Participants	52.39 Years STANDARD_DEVIATION 12.69 • n=7 Participants	56.7 Years STANDARD_DEVIATION 13.76 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Delayed Graft Function	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months from enrollment

A Viral load of <600 copies/mL for at least 3 months indicates sustained clearance of BK viremia, confirmed by blood test

Outcome measures

Measure	Standard Immunosuppression Reduction Arm n=20 Participants 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).	mTOR Substitution Arm n=20 Participants 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).
Number of Participants With BK Viral Load <600 Copies/mL	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 24 months from randomization

The number of people with incidence of BK Nephropathy in each of the two Arms

Outcome measures

Measure	Standard Immunosuppression Reduction Arm n=20 Participants 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).	mTOR Substitution Arm n=20 Participants 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).
Number of Participants With Incidence of BK Nephropathy	3 Participants	1 Participants

Adverse Events

Standard Immunosuppression Reduction Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

mTOR Substitution Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Immunosuppression Reduction Arm n=20 participants at risk 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).	mTOR Substitution Arm n=20 participants at risk 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).
Renal and urinary disorders Proteinuria	5.0% 1/20 • Number of events 1 • Up to 24 months	0.00% 0/20 • Up to 24 months
Respiratory, thoracic and mediastinal disorders Rapa Pneumonitis	0.00% 0/20 • Up to 24 months	5.0% 1/20 • Number of events 1 • Up to 24 months

Other adverse events

Adverse event data not reported

Additional Information

Sumit Mohan, MD

Columbia University Medical Center

Phone: 2123053273

Email: sm2206@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place