Trial Outcomes & Findings for Tacrolimus to Sirolimus Conversion for Delayed Graft Function (NCT NCT00931255)

NCT ID: NCT00931255

Last Updated: 2022-03-31

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: One year
• Results posted on: 2022-03-31

Participant Flow

Participant milestones

Measure	Tacrolimus Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Overall Study STARTED	17	15
Overall Study COMPLETED	15	12
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Tacrolimus Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Overall Study Follow up biopsy not done	2	3

Baseline Characteristics

Tacrolimus to Sirolimus Conversion for Delayed Graft Function

Baseline characteristics by cohort

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol	Total n=32 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 9.7 • n=5 Participants	49.9 years STANDARD_DEVIATION 10.1 • n=7 Participants	51.7 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Outcome measures

Measure	Tacrolimus n=15 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=12 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
The Composite Endpoint of Reduction of e eGFR at One Year by More Than 15% & the Progression in Fibrosis Score at One Year by >=20% Compared With the Baseline Values	6 participants	9 participants

SECONDARY outcome

Timeframe: One year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
eGFR	56.4 mL/min per 1.73 m^2 Standard Deviation 15.2	53.7 mL/min per 1.73 m^2 Standard Deviation 19.2

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Change in eGFR From Baseline to 1-year	7.45 mL/min per 1.73 m^2 Standard Deviation 11.5	1.57 mL/min per 1.73 m^2 Standard Deviation 10.7

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Graft Survival (Actual, Actuarial)	16 participants	14 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Incidence of Acute Rejection (Actual, Actuarial)	1 participants	1 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Incidence of BK Nephropathy (Cumulative)	1 participants	0 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Change in Inflammatory Marker : CRP From Baseline	-1668 mg/L Standard Deviation 9403	4510 mg/L Standard Deviation 14495

SECONDARY outcome

Timeframe: 1 Year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Change in Inflammatory Marker, IL-6 From Baseline	-0.7 pg/mL Standard Deviation 8.53	6.2 pg/mL Standard Deviation 14.1

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Tacrolimus n=17 Participants Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 Participants 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Change in Inflammatory Marker, MCP, From Baseline	-787.5 pg/mL Standard Deviation 693.9	-965.2 pg/mL Standard Deviation 753.6

Adverse Events

Tacrolimus

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sirolimus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tacrolimus n=17 participants at risk Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year. Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol	Sirolimus n=15 participants at risk 5 mg, PO , daily Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Blood and lymphatic system disorders CMV viremia	5.9% 1/17 • Number of events 1	0.00% 0/15

Additional Information

Abdolreza Haririan, MD

UMaryland

Phone: 410-328-5720

Email: ahariria@medicine.umaryland.edu

Results disclosure agreements

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