Trial Outcomes & Findings for Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO) (NCT NCT01438710)
NCT ID: NCT01438710
Last Updated: 2015-10-01
Results Overview
The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion. The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor. Below the mean total score and standard deviation for each treatment is given in addition to the mean change.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
14 days
Results posted on
2015-10-01
Participant Flow
Participant milestones
| Measure |
LCP-Tacro
After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.
LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
|
Prograf
All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.
Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.
|
|---|---|---|
|
First Week of Treatment
STARTED
|
0
|
44
|
|
First Week of Treatment
COMPLETED
|
0
|
41
|
|
First Week of Treatment
NOT COMPLETED
|
0
|
3
|
|
Second Week of Treatment
STARTED
|
41
|
0
|
|
Second Week of Treatment
COMPLETED
|
40
|
0
|
|
Second Week of Treatment
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
Baseline characteristics by cohort
| Measure |
Prograf
n=44 Participants
Tacrolimus capsules for twice daily oral administration
Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 13.68 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=93 Participants
|
|
Target Trough Range (low), ng/mL
|
5.72 ng/mL
STANDARD_DEVIATION 1.912 • n=93 Participants
|
|
Target Trough Range (high), ng/mL
|
8.68 ng/mL
STANDARD_DEVIATION 1.863 • n=93 Participants
|
|
Height, cm
|
173.63 cm
STANDARD_DEVIATION 8.424 • n=93 Participants
|
|
Weight, kg
|
88.16 kg
STANDARD_DEVIATION 19.707 • n=93 Participants
|
|
BMI, kg/m2
|
29.20 kg/m2
STANDARD_DEVIATION 5.979 • n=93 Participants
|
|
Time from current kidney transplant to enrolment, months
|
16.85 Months
STANDARD_DEVIATION 14.455 • n=93 Participants
|
|
Donor type for current kidney transplant, n
Living donor
|
15 participants
n=93 Participants
|
|
Donor type for current kidney transplant, n
Deceased donor
|
29 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Of the 40 patients who completed the study period, 38 patients were evaluable for efficacy evaluation and included in the modified intention to treat (mITT) population. The outcome measure is given as total score below.
The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion. The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor. Below the mean total score and standard deviation for each treatment is given in addition to the mean change.
Outcome measures
| Measure |
LCP-Tacro
n=38 Participants
After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.
LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
|
|---|---|
|
Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.
Mean change
|
-5.35 units on a scale
Standard Deviation 7.501
|
|
Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.
Total score day 7 (Prograf)
|
25.30 units on a scale
Standard Deviation 9.472
|
|
Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.
Total score day 14 (LCP-Tacro)
|
19.96 units on a scale
Standard Deviation 7.613
|
Adverse Events
LCP-Tacro
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Prograf
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCP-Tacro
n=41 participants at risk
After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.
LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
|
Prograf
n=44 participants at risk
All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.
Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.
|
|---|---|---|
|
Infections and infestations
Incision Site Cellulitis
|
0.00%
0/41 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
2.3%
1/44 • Number of events 1 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
Other adverse events
| Measure |
LCP-Tacro
n=41 participants at risk
After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.
LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
|
Prograf
n=44 participants at risk
All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.
Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 2 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
0.00%
0/44 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/41 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
6.8%
3/44 • Number of events 3 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
|
Investigations
Cardiac Murmur
|
0.00%
0/41 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
4.5%
2/44 • Number of events 2 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/41 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
4.5%
2/44 • Number of events 2 • Each patient was followed for 25 months.
AE threshold is defined as 5% per treatment arm; i.e. at least 2 patients in the treatment arm have experienced the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER