---
title: Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
nct_id: NCT00413920
overall_status: COMPLETED
phase: PHASE3
sponsor: Novartis
study_type: INTERVENTIONAL
primary_condition: Renal Transplantation
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00413920.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00413920"
ct_last_update_post_date: 2011-04-21
last_seen_at: "2026-05-12T06:10:23.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients

**Official Title:** A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Microemulsion, in de Novo Adult Renal Transplant Recipients

**NCT ID:** [NCT00413920](https://clinicaltrials.gov/study/NCT00413920)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 222
- **Lead Sponsor:** Novartis
- **Conditions:** Renal Transplantation
- **Start Date:** 2007-04
- **CT.gov Last Update:** 2011-04-21

## Brief Summary

This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Primary donor kidney transplant
* Panel reactive antibody (PRA) ≤ 20%

Exclusion Criteria:

* Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
* Non-heart beating donor or kidney from a non-compatible donor

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

## Arms

- **Without Steroids** (EXPERIMENTAL) — Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
- **With Steroids** (ACTIVE_COMPARATOR) — Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.

## Interventions

- **Enteric-coated mycophenolate sodium (EC-MPS)** (DRUG) — An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.
- **Prednisone** (DRUG) — Oral tablets

## Primary Outcomes

- **Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation** _(time frame: 6 months post transplantation)_ — Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.

## Secondary Outcomes

- **The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months** _(time frame: Month 6)_
- **Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months** _(time frame: Month 3)_
- **Number of Participants With Subclinical Histological Rejections** _(time frame: Month 3)_
- **Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status** _(time frame: Month 3)_
- **Number of Participants Requiring Steroids in Non-steroid Treatment Group** _(time frame: Months 3 and 6)_

## Locations (1)

- C.H.U. La Milétrie, Poitiers, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — 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.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.c.h.u. la milétrie|poitiers||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00413920.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00413920*  
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