## Protocol Section
### Identification Module
**NCT ID:** NCT00238979

**Brief Title:** A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

**Official Title:** A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

#### Organization Study ID Info
**ID:** CERL080ADE03
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-11-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-11-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-02

**Type:** ACTUAL

#### Start Date
**Date:** 2003-01

**Status Verified Date:** 2011-11

#### Study First Post Date
**Date:** 2005-10-14
**Type:** ESTIMATED
**Study First Submit Date:** 2005-10-12
**Study First Submit QC Date:** 2005-10-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.

### Conditions Module

**Conditions:**

- Renal Transplantation

**Keywords:**

- Renal transplantation, Enteric-coated mycophenolate sodium

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 50

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Enteric-Coated Mycophenolate Sodium (EC-MPS)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.

#### Secondary Outcomes

**Measure:** Safety based on renal function within 6 months after medication switch.

**Measure:** Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3

**Measure:** Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3

**Measure:** Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.

**Measure:** Graft survival and patient survival 6 months post medication switch.

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
* Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
* In a stable condition in terms of graft function.

Exclusion criteria:

* Patients who had taken an investigational drug within four weeks prior to study entry
* History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
* Thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<2,500/mm3), and/or hemoglobin \<6.0 g/dL prior to enrollment
* Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.

Other protocol-defined inclusion/exclusion criteria may apply.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Novartis

**Name:** Novartis

**Role:** STUDY_DIRECTOR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000904

- Term: Antibiotics, Antitubercular

- ID: D000000995

- Term: Antitubercular Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12128

- Name: Mycophenolic Acid

- Relevance: HIGH

- As Found: Exhaled

- ID: M18950

- Name: Tacrolimus

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009173

- Term: Mycophenolic Acid

### Misc Info Module

- Version Holder: 2024-05-24
