---
title: Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
nct_id: NCT00238940
overall_status: COMPLETED
phase: PHASE3
sponsor: Novartis
study_type: INTERVENTIONAL
primary_condition: Renal Transplantation
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00238940.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00238940"
ct_last_update_post_date: 2011-01-31
last_seen_at: "2026-05-12T06:02:52.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

**Official Title:** A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients

**NCT ID:** [NCT00238940](https://clinicaltrials.gov/study/NCT00238940)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 55
- **Lead Sponsor:** Novartis
- **Conditions:** Renal Transplantation
- **Start Date:** 2003-02
- **Completion Date:** 2005-09
- **CT.gov Last Update:** 2011-01-31

## Brief Summary

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

```
Inclusion/ Exclusion criteria

\- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

Other protocol-defined inclusion/exclusion criteria may apply.
```

## Interventions

- **Enteric-Coated Mycophenolate Sodium (EC-MPS)** (DRUG)

## Primary Outcomes

- **Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.**

## Secondary Outcomes

- **Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.**
- **Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation**
- **Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup**
- **Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.**
- **Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.**

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00238940.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00238940*  
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