MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive

A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00284921

Enrollment

Registered

2006-02-01

Start date

2004-04-30

Completion date

Unknown

Last updated

2011-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

De Novo Kidney Transplant

Keywords

kidney transplant, hepatitis C, enteric-coated mycophenolate sodium

Brief summary

To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.

Interventions

DRUGEnteric-coated Mycophenolate sodium (EC-MPS)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

1. Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay). 2. Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.

Exclusion criteria

1. Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ. 2. Kidneys from non-heart beating donors. 3. ABO incompatibility against the donor. 4. Patients with panel reactive antibodies of \>50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Hepatic function tests (ALT/AST) after 12 months treatment.	—

Secondary

Measure	Time frame
Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.	—
Glomerular filtration rate and by proteinuria after 12 months treatment.	—
Graft survival after 12 months.	—
Incidence of AEs and SAEs after 3 and 12 months.	—
Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.	—
Percentage of patients free of steroids at 12 months between the two investigational groups.	—
Viral load (HCV RNA) between both groups at 12 months.	—
Bone density at 12 months in both groups.	—
Blood pressure, lipids and glucose profiles after 3 and 12 months.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026