## Protocol Section
### Identification Module
**NCT ID:** NCT00171379

**Brief Title:** Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant

**Official Title:** Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant

#### Organization Study ID Info
**ID:** CERL080AIT01
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2005-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-02-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-02-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-06

**Type:** ACTUAL

#### Start Date
**Date:** 2004-03

**Status Verified Date:** 2011-02

#### Study First Post Date
**Date:** 2005-09-15
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-12
**Study First Submit QC Date:** 2005-09-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis

#### Responsible Party

**Old Name Title:** Novartis External Affairs

**Old Organization:** Novartis Pharmaceuticals

### Description Module

**Brief Summary:** The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.

### Conditions Module

**Conditions:**

- Prevention of Acute Rejection After Kidney Transplantation

**Keywords:**

- Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium.

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 162

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Enteric-Coated Mycophenolate Sodium

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

#### Secondary Outcomes

**Measure:** Incidence of biopsy proven acute rejection

**Measure:** Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)

**Measure:** Quality of life related to GI symptoms (GIQLI scale)

**Measure:** Full blood count

**Measure:** Gastrointestinal Adverse Events (check-list)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* First or second (single or double) deceased or living donor kidney transplant received at least six months previously;

  * Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
  * Receiving an MMF dose of \<2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF

Exclusion Criteria:

* • Subjects expected to discontinue cyclosporin therapy;

  * Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline;
  * Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months.

**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

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### 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: 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
