Trial Outcomes & Findings for Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant. (NCT NCT00446459)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Enrollment to month 8

Results posted on

2010-04-15

Participant Flow

All study subjects were recruited from University of Washington Medical Center's kidney transplant wait list. Patients with a Panel of Reactive Antibodies (PRA)over 50% for 6 months or longer between 18 and 75 year of age were contacted by letter and then by phone to schedule screening visit. Enrollment occured from 4/24/06 to 9/06/07.

Subjects were consented, given a physical exan and laboratory tests including serum virologies current Hepatitis B immunization and Tuberculosis (TB) testing initially. Abnormalities in white or red blood cells, platelets, TB test or signs of infection or evidence of cancer were grounds for exclusion.

Participant milestones

Participant milestones
Measure	Mycophenolate Mofetil (MMF) Single Arm Study MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
8 Months STARTED	34
8 Months COMPLETED	22
8 Months NOT COMPLETED	12
12 Months STARTED	22
12 Months COMPLETED	4
12 Months NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Mycophenolate Mofetil (MMF) Single Arm Study MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
8 Months Protocol Violation	12
12 Months Protocol Violation	4
12 Months 14 subjects to MMF + Rituximab Study	14

Baseline Characteristics

Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=34 Participants MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	46.5 years STANDARD_DEVIATION 11.2 • n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Region of Enrollment United States	34 participants n=99 Participants

PRIMARY outcome

Timeframe: Enrollment to month 8

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=34 Participants MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
The Number of Subjects With a 10% Decrease in PRA Level at Month 8.	9 Participant

SECONDARY outcome

Timeframe: From enrollment to month 12.

Population: Forty five subjects were screened, of these 37 received MMF.

The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=34 Participants MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
The Number of Subjects With Significant Infections up to Month 12.	4 Participants

SECONDARY outcome

Timeframe: Enrollment to month 8 or month 12 post enrollment.

The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=34 Participants MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
The Number of Kidney Transplant up to 12 Months.	3 Participants

SECONDARY outcome

Timeframe: Enrollment to month 12.

The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months.

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=34 Participants MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL).	0 Participant

SECONDARY outcome

Timeframe: Number of Transplants with a Negative Crossmatch.

The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months.

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=34 Participants MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
The Number of Transplants With a Negative Crossmatch at Transplant.	0 Participant

Adverse Events

Mycophenolate Mofetil (MMF) Single Arm Study

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=37 participants at risk MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
Cardiac disorders Myocardial infarction	2.7% 1/37 • Number of events 1 • From enrollment to month 12. Definition of SAE: hospitalization or significant treatment or interference with ADLs.
Cardiac disorders Retinal stroke	2.7% 1/37 • Number of events 1 • From enrollment to month 12. Definition of SAE: hospitalization or significant treatment or interference with ADLs.

Other adverse events

Other adverse events
Measure	Mycophenolate Mofetil (MMF) Single Arm Study n=37 participants at risk MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
Infections and infestations Peritonitis	5.4% 2/37 • Number of events 2 • From enrollment to month 12. Definition of SAE: hospitalization or significant treatment or interference with ADLs.
Blood and lymphatic system disorders Anemia	8.1% 3/37 • Number of events 3 • From enrollment to month 12. Definition of SAE: hospitalization or significant treatment or interference with ADLs.
Infections and infestations Abscess	5.4% 2/37 • Number of events 3 • From enrollment to month 12. Definition of SAE: hospitalization or significant treatment or interference with ADLs.

Additional Information

Dr. Connie L. Davis

University of Washington

Phone: 206-598-7162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60