Trial Outcomes & Findings for Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity (NCT NCT01473732)
NCT ID: NCT01473732
Last Updated: 2018-10-16
Results Overview
Estimated glomerular filtration rate (eGFR) indicates kidney function. Normal eGFR value for healthy is 80-120ml/min. For transplants, it is expected to be 60-80 ml/min.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Baseline, One year
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)
Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
|
Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)
Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)
Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
|
Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)
Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity
Baseline characteristics by cohort
| Measure |
Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)
n=2 Participants
Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
|
Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)
Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 2 • n=99 Participants
|
—
|
63 years
STANDARD_DEVIATION 2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, One yearPopulation: The only two patients enrolled did not reach the one year mark; they did not complete the study so there was no data to analyze.
Estimated glomerular filtration rate (eGFR) indicates kidney function. Normal eGFR value for healthy is 80-120ml/min. For transplants, it is expected to be 60-80 ml/min.
Outcome measures
Outcome data not reported
Adverse Events
Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Everolimus (Zortress)+ Mycophenolic Acid(Myfortic)
n=2 participants at risk
Everolimus: Starting dose 1.5 mg bid, target trough level 6-10 ng/ml. Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Both for one year.
|
Reduced Dose Prograf+ Mycophenolic Acid(Myfortic)
Tacrolimus: Target trough level of Tacrolimus 3-5 ng/ml. Myfortic Min. 360 mg bid and Max. 720 mg bid Both for one year.
|
|---|---|---|
|
Renal and urinary disorders
proteinuria
|
50.0%
1/2 • Number of events 1 • The only two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria. The first participant was enrolled in March of 2012 and the study was terminated in August 2012.
The two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria discontinued everolimus and switched to tacrolimus. The death occurred two months after enrollment. The proteinuria event occurred fours months after enrollment. No patient enrolled in reduced tacrolimus dose group and due to difficulty in enrollment the study is terminated. No data was analyzed for any participant.
|
—
0/0 • The only two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria. The first participant was enrolled in March of 2012 and the study was terminated in August 2012.
The two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria discontinued everolimus and switched to tacrolimus. The death occurred two months after enrollment. The proteinuria event occurred fours months after enrollment. No patient enrolled in reduced tacrolimus dose group and due to difficulty in enrollment the study is terminated. No data was analyzed for any participant.
|
|
Gastrointestinal disorders
Small bowel obstruction leading to death
|
50.0%
1/2 • Number of events 1 • The only two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria. The first participant was enrolled in March of 2012 and the study was terminated in August 2012.
The two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria discontinued everolimus and switched to tacrolimus. The death occurred two months after enrollment. The proteinuria event occurred fours months after enrollment. No patient enrolled in reduced tacrolimus dose group and due to difficulty in enrollment the study is terminated. No data was analyzed for any participant.
|
—
0/0 • The only two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria. The first participant was enrolled in March of 2012 and the study was terminated in August 2012.
The two patients enrolled in everolimus group did not complete the study due to events leading to death and one due to proteinuria discontinued everolimus and switched to tacrolimus. The death occurred two months after enrollment. The proteinuria event occurred fours months after enrollment. No patient enrolled in reduced tacrolimus dose group and due to difficulty in enrollment the study is terminated. No data was analyzed for any participant.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Enver Akalin, Medical Director Kidney Transplant
Montefiore Medical Center
Phone: 718-920-4815
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place