At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 32 enrolled
Drug / intervention
Myfortic Escalationdrug
Likely dose
Myfortic Escalation 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory, Open-Label, Single Center Study to Assess the Efficacy and Dose Titration of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients
In Brief
A Phase 4 clinical trial evaluating Myfortic Escalation for Transplant; Failure, Kidney. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransplant; Failure, Kidney
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedJan 2010
Primary CompletionApr 2013
TodayJul 2026
First PostedJan 7, 2010
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.5 years ago
Interventions
Myfortic Escalationdrug
Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily.