Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) Plus Valsartan in Patients With Kidney Transplants (MYTHOS

Effect of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Valsartan as Part of Intensified Multi-factorial Intervention Compared to EC-MPS Plus Standard Practice of Care on Development of Transplant Nephropathy in Cadaver Donor Kidney Recipients Given Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Short-term Steroids: a 12-month, Prospective, Randomized, Open-label Multicentre Study (MYTHOS)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00308425

Enrollment

119

Registered

2006-03-29

Start date

2002-10-31

Completion date

2005-06-30

Last updated

2011-01-31

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

Conditions

De Novo Renal Transplantation

Keywords

Renal transplantation, EC-MPS

Brief summary

The primary aim of this study is to evaluate the safety and efficacy of EC-MPS plus valsartan as part of an intensified multifactorial intervention on the reduction of the 12-month rate of transplant nephropathy compared with EC-MPS plus standard practice of care in recipients of a first cadaver donor kidney transplant given CsA-ME, basiliximab, and short-term steroids.

Interventions

DRUGEnteric-coated Mycophenolate sodium (EC-MPS), valsartan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Inclusion criteria

1\. Male and female patients aged 18 to 70 years 2. Patients receiving a first kidney transplant from a cadaver donor, who are scheduled to receive CsA-ME and anti-CD25 antibody as primary immunosuppression; 3. Patients able to receive the first dose of EC-MPS within 48 hours of graft reperfusion

Exclusion criteria

1. Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ. 2. Recipient of a kidney from a non-heart beating, from a cadaver donor aged more than 70 years, or with cold ischemia time of more than 36 hours 3. Recipient who is HLA-identical to the donor 4. Patients with a PRA level (past or current level) higher than 50% 5. Patients with a known hypersensitivity to EC-MPS or other components of the formulation (e.g. lactose). 6. Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline. 7. HIV-positive 8. Positive HBsAg test for both donor and recipients. 9. Unstable angina, acute myocardial infarction or stroke during the last 6 month or heart failure NYHA class III-IV or hemodinamically significant valvular heart disease 10. Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN 11. Creatinine kinase (CK) levels greater than 5 x ULN. Additional protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
12-month rate of success in preventing relapse of nephropathy, defined as persistent albumin excretion rate (AER) > 300 mg/24h and safety, compared between groups.	—

Secondary

Measure	Time frame
Glomerular filtration rate (GFR), as plasma clearance of unlabeled iohexol, after 6 and 12 months;	—
Albumin excretion rate and fractional clearance of albumin after 6 and 12 months;	—
Renal function, as measured by serum creatinine and calculated creatinine clearance after 6 and 12 months;	—
Incidence of acute rejection after 6 and 12 months;	—
Patient and graft survival at 12 months;	—
Fasting blood glucose levels, total cholesterol, triglyceride and HDL levels and systolic and diastolic blood pressure after 6 and 12 months;	—

Outcome results

None listed

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