Trial Outcomes & Findings for Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily (NCT NCT00817206)

NCT ID: NCT00817206

Last Updated: 2015-09-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

326 participants

Primary outcome timeframe

12 months

Results posted on

2015-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	LCP-Tacro LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK) LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.	Prograf (Tacrolimus) Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL) Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
Overall Study STARTED	163	163
Overall Study COMPLETED	142	154
Overall Study NOT COMPLETED	21	9

Reasons for withdrawal

Reasons for withdrawal
Measure	LCP-Tacro LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK) LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.	Prograf (Tacrolimus) Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL) Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
Overall Study Adverse Event	10	3
Overall Study Protocol Violation	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Death	2	0
Overall Study Withdrawal by Subject	7	3
Overall Study Physician Decision	2	0

Baseline Characteristics

Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LCP-Tacro n=163 Participants LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK) LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.	Prograf (Tacrolimus) n=163 Participants Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL) Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.	Total n=326 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	146 Participants n=5 Participants	137 Participants n=7 Participants	283 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	26 Participants n=7 Participants	43 Participants n=5 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 11.71 • n=5 Participants	50.2 years STANDARD_DEVIATION 13.49 • n=7 Participants	50.3 years STANDARD_DEVIATION 1.61 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	61 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	102 Participants n=7 Participants	219 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	137 Participants n=5 Participants	134 Participants n=7 Participants	271 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 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	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) White	120 Participants n=5 Participants	117 Participants n=7 Participants	237 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	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	121 participants n=7 Participants	243 participants n=5 Participants
Region of Enrollment Europe	41 participants n=5 Participants	42 participants n=7 Participants	83 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: One patient in each arm were randomized but not treated. Only treated patients (modified ITT population) is included in the primary outcome measure. One patient death is listed under the Prograf arm; this patient died during follow up and did completet the study.

Outcome measures

Outcome measures
Measure	LCP-Tacro n=162 Participants LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK) LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.	Prograf (Tacrolimus) n=162 Participants Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL) Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up. Death	2 participants	1 participants
Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up. Graft Failure	0 participants	0 participants
Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up. BPAR	1 participants	4 participants
Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up. Loss to follow up	0 participants	1 participants

Adverse Events

LCP-Tacro

Serious events: 36 serious events

Other events: 135 other events

Deaths: 0 deaths

Prograf (Tacrolimus)

Serious events: 26 serious events

Other events: 133 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	LCP-Tacro n=162 participants at risk LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK) LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.	Prograf (Tacrolimus) n=162 participants at risk Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL) Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
Gastrointestinal disorders Diarrhoea	13.6% 22/162 • Number of events 31 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	9.3% 15/162 • Number of events 17 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Gastrointestinal disorders Nausea	6.2% 10/162 • Number of events 13 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	3.7% 6/162 • Number of events 6 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Infections and infestations Nasopharyngitis	9.3% 15/162 • Number of events 16 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	11.1% 18/162 • Number of events 24 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Infections and infestations Urinary tract infection	8.6% 14/162 • Number of events 19 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	13.6% 22/162 • Number of events 39 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Infections and infestations Upper respiratory tract infection	7.4% 12/162 • Number of events 13 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	8.6% 14/162 • Number of events 16 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Investigations Blood creatinine increased	12.3% 20/162 • Number of events 20 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	8.6% 14/162 • Number of events 16 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
General disorders Oedema Peripheral	6.8% 11/162 • Number of events 12 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	6.2% 10/162 • Number of events 11 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 7/162 • Number of events 10 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	5.6% 9/162 • Number of events 11 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Nervous system disorders Headache	9.3% 15/162 • Number of events 18 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	6.8% 11/162 • Number of events 12 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Nervous system disorders Dizziness	5.6% 9/162 • Number of events 10 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	3.1% 5/162 • Number of events 5 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Respiratory, thoracic and mediastinal disorders Cough	5.6% 9/162 • Number of events 9 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	4.3% 7/162 • Number of events 8 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).
Vascular disorders Hypertension	4.3% 7/162 • Number of events 8 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).	6.2% 10/162 • Number of events 11 • SAEs were collected for 1 year for all patients receiving at least one dose of study drug (mITT population).

Additional Information

Christina Sylvest

Veloxis Pharmaceuticals A/S

Phone: +45 20553877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER