Trial Outcomes & Findings for Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study) (NCT NCT01044303)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

24 months

Results posted on

2014-10-20

Participant milestones
Measure	Mycophenolic Acid Escalation Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations. Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily.
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Mycophenolic Acid Escalation Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations. Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily.
Overall Study Lost to Follow-up	2

Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)

Baseline characteristics by cohort
Measure	Mycophenolic Acid Escalation n=32 Participants Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations. Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

Timeframe: 24 months

Population: This was a pilot study to examine the effect of MPA escalation on DSA reduction.

Outcome measures
Measure	Mycophenolic Acid (MPA) Escalation n=30 Participants Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months	Rate of Rejection Number of patients who had a rejection during the course of the study.	Renal Function Number of patients who had stable renal function throughout the study.
Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)	43.1 percent of MFI change Standard Deviation 31.45	—	—

Timeframe: 24 months

Outcome measures
Measure	Mycophenolic Acid (MPA) Escalation n=30 Participants Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months	Rate of Rejection n=30 Participants Number of patients who had a rejection during the course of the study.	Renal Function n=30 Participants Number of patients who had stable renal function throughout the study.
To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.	2 participants	2 participants	29 participants

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	Adverse Events n=30 participants at risk Adverse events reported by participants during the course of the study.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Diarrhea	6.7% 2/30 • Number of events 2
Endocrine disorders Pancreatitis	3.3% 1/30 • Number of events 1
Blood and lymphatic system disorders Sepsis	3.3% 1/30 • Number of events 1

Other adverse events
Measure	Adverse Events n=30 participants at risk Adverse events reported by participants during the course of the study.
Gastrointestinal disorders Diarrhea	10.0% 3/30 • Number of events 3
Blood and lymphatic system disorders CMV	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1

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