Condition category
Surgery
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.W. Fijter, de

ORCID ID

Contact details

Leiden University Medical Center
Department of Nephrology
C3-P22
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262169
jwdefijter@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Added 26/08/09: Prospective, open label, randomised multicentre study to compare Area Under the Curve (AUC)-monitored withdrawal of either cyclosporin (Neoral®) or mycophenolate mofetil (MMF) (CellCept®) in stable renal transplant recipients on a triple regimen with cyclosporin, MMF and steroids.

Acronym

NICE

Study hypothesis

To compare the safety, efficacy, and impact on non-immune toxicity of AUC-controlled withdrawal of either cyclosporine or MMF in stable renal transplant recipients currently on a triple maintenance regimen with cyclosporin, MMF and steroids.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Renal transplant

Intervention

Randomised, controlled, prospective multicentre study in stable renal transplant recipients, at least 6 months post-transplantation, who receive maintenance immunosuppressive treatment with cyclosporin bid, MMF 1 g bid, and steroids.
In eligible patients, systemic drug exposure (cyclosporin, MMF) will be measured by a 12-hour area under the time-blood concentration curve (AUC0-12) before randomisation to one of the three study arms.
Patients will be randomised 1:1:1 with stratification for the occurrence of previous acute rejection episodes.
Group A will continue on their current treatment regimen aiming at C2 levels of 700 ng/ml, (range: 600-800 ng/ml). In this group AUC-values will be blinded to the clinicians and evaluated retrospectively.
In group B (MMF withdrawal) cyclosporin will be dosed to reach the defined target AUC0-12 of 3250 ng.h/ml (range 3000-3500 ng.h/ml).
In group C (cyclosporin withdrawal) MMF will be given at a fixed dose of 1000 mg bid at the start of the study period. After cessation of the cyclosporine AUC will be measured to adjust the dose to reach the defined MPA-AUC0-12 target of 75 mg.h/ml (range 60-90 ng.h/ml). For safety reasons the minimal dose will be 500 mg bid.

Intervention type

Drug

Phase

Not Specified

Drug names

Cyclosporin (Neoral®), mycophenolate mofetil (MMF) (CellCept®)

Primary outcome measures

1. Composite of Graft function
2. Incidence of acute rejection episodes
3. Graft and patient survival

Secondary outcome measures

1. Non-immune toxicity
2. Hypertension
3. Hyperlipedimia
4. Gout, uric acid
5. Magnesium
6. Nausea, dyspepsia, diarrhea
7. Anemia/Leukopenia/Thrombopenia
8. Infections (clinically defined)
9. Post-transplant lympho-proliferative disease
10. Malignancy

Overall trial start date

01/01/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients, 18 years or older, on maintenance therapy with cyclosporin, MMF and steroids
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Calculated creatinine clearance 20 ml/min
2. Multi-organ recipients
3. Patients with an (historic) PRA >60%
4. Vascular type rejection in the past
5. Patients with more than two acute rejection episodes in the past
6. Third renal transplant or more
7. Patients receiving other investigational drugs than MMF in combination with Neoral
8. Metastatic neoplasms, post-transplant lymphoproliferative disease

Recruitment start date

01/01/2003

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Roche Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novartis Pharma BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes