NCT01044303

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The development of DSA post-transplant has been associated with chronic rejection and graft failure. EC-MPS is thought to be the key drug preventing both cellular and antibody mediated rejections. Several studies have shown that recipients receiving an optimal dose of EC-MPS have fewer antibody mediated rejections and may require a lower dose of calcineurin inhibitors and/or corticosteroids thus reducing side effects and extending graft survival.

Conditions

• Transplant; Failure, Kidney

Interventions

Type	Name	Description
DRUG	Myfortic Escalation	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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-01-07
• Last updated: 2014-10-20
• Results posted: 2014-10-20

Locations

1 site across 1 country: United States