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

NCT00308425 | Completed Phase 3

• 1 other identifier: CERL080A2405IT02
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

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.

Conditions

De Novo Renal Transplantation

Keywords

Renal transplantation, EC-MPS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Renal function, as measured by serum creatinine and calculated creatinine clearance after 6 and 12 months;

• 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;

• Fasting blood glucose levels, total cholesterol, triglyceride and HDL levels and systolic and diastolic blood pressure after 6 and 12 months;

• Incidence of acute rejection after 6 and 12 months;

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS), valsartan DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Multi-organ recipients (e.g. kidney and pancreas, double kidney) or previous transplant with any other organ.
• 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
• Recipient who is HLA-identical to the donor
• Patients with a PRA level (past or current level) higher than 50%
• Patients with a known hypersensitivity to EC-MPS or other components of the formulation (e.g. lactose).
• 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.
• HIV-positive
• Positive HBsAg test for both donor and recipients.
• 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
• Liver injury as indicated by transaminase serum levels (ALT and/or AST) greater than 2 x ULN

Sponsors & Collaborators

• Novartis: lead

Related Publications (1)

• Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

  PMID: 39082471 DERIVED

MeSH Terms

Interventions

Valsartan

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 29, 2006
• Study Start: October 1, 2002
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: January 31, 2011

Record last verified: 2011-01