---
title: Observational Registry Study of Renal Transplant Patients
nct_id: NCT01284257
overall_status: WITHDRAWN
sponsor: Novartis Pharmaceuticals
study_type: OBSERVATIONAL
primary_condition: Kidney Transplant
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01284257.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01284257"
ct_last_update_post_date: 2017-02-27
last_seen_at: "2026-05-12T07:14:53.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Observational Registry Study of Renal Transplant Patients

**Official Title:** A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice

**NCT ID:** [NCT01284257](https://clinicaltrials.gov/study/NCT01284257)

## Key Facts

- **Status:** WITHDRAWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Novartis Pharmaceuticals
- **Conditions:** Kidney Transplant
- **Start Date:** 2007-06
- **Completion Date:** 2010-05
- **CT.gov Last Update:** 2017-02-27

## Brief Summary

The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.

## Eligibility

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

```
Inclusion Criteria:

* 18 years of age or older.
* The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.
* Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.
* Able to provide informed consent.
* Able to self-administer the ITAS compliance instrument (6 questions).

Exclusion Criteria:

* The recipient of multiple organ grafts or prior non-kidney graft.
* Enrolled or plans to enroll in an investigational clinical trial.
* Not likely to have up to 5 year follow-up data available for this study.
```

## Arms

- **Enteric coated mycophenolate sodium (EC-MPS) arm** — Patients to whom EC-MPS is prescribed by their practitioner.
- **MMF arm** — Patients to whom MMF is prescribed by their practitioner.

## Primary Outcomes

- **Dosage of EC-MPS or MMF over time** _(time frame: 60 months)_ — Dosage interruptions, discontinuations and switches between EC-MPS and MMF

## Secondary Outcomes

- **Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications** _(time frame: 60 months)_
- **The incidence of selected Adverse Events** _(time frame: 60 months)_
- **Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death** _(time frame: 60 months)_
- **Center Practices** _(time frame: 60 months)_

## Locations (8)

- San Francisco investigational site, San Francisco, California, United States
- Denver Investigational site, Denver, Colorado, United States
- Springfield investigational site, Springfield, Massachusetts, United States
- Detroit investigational site, Detroit, Michigan, United States
- New York investigational site, New York, New York, United States
- PHILADELPHIA investigational site, Philadelphia, Pennsylvania, United States
- BURLINGTON investigational site, Burlington, Vermont, United States
- Seattle investigational site, Seattle, Washington, United States

## 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.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — 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)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.san francisco investigational site|san francisco|california|united states` — added _(2026-05-12)_
- `locations.denver investigational site|denver|colorado|united states` — added _(2026-05-12)_
- `locations.springfield investigational site|springfield|massachusetts|united states` — added _(2026-05-12)_
- `locations.detroit investigational site|detroit|michigan|united states` — added _(2026-05-12)_
- `locations.new york investigational site|new york|new york|united states` — added _(2026-05-12)_
- `locations.philadelphia investigational site|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.burlington investigational site|burlington|vermont|united states` — added _(2026-05-12)_
- `locations.seattle investigational site|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01284257.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01284257*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*