Condition category
Surgery
Date applied
16/05/2005
Date assigned
08/07/2005
Last edited
16/09/2009
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 Pasupathy Sivasothy

ORCID ID

Contact details

Transplant Unit
Papworth Hospital NHS Trust
Papworth Everard
CB3 8RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P00784

Study information

Scientific title

Acronym

Study hypothesis

Does improved control of the variability in exposure to cyclosporin by monitoring C2 in lung transplant recipients help to reduce the propensity of these patients to cyclosporin-associated side effects whilst maintaining effective immunosupression?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lung transplant recipients

Intervention

Patients will be randomised into 3 groups to compare the clinical value of both 'high' and 'low' C2 monitoring strategies with conventional C12 monitoring as a guide to cyclosporin Neoral dosage adjustment after lung transplantation.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Renal function at 3 months post transplant

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

90 patients lung transplant:
1. Adult single or double lung and heart + lung transplant recipients (18 years and older)
2. Patients receiving Neoral as primary immunosuppression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Patients not giving voluntary, written informed consent to participate
2. Re-transplantation
3. Simultaneous kidney, pancreas, liver or bowel transplantation
3. Urine output <50 ml/hour and/or serum creatinine ≥170 mmol/l at the most recent investigation prior to transplantation
4. Renal replacement therapy or any form of renal support such as continuous veno-venous haemofiltration (CVVH) or dialysis before transplantation or within the first post-operative week
5. Patients receiving tacrolimus or sirolimus as primary immuno-suppression in place of Neoral

Recruitment start date

01/04/2003

Recruitment end date

01/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Transplant Unit
Papworth Everard
CB3 8RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals (UK)

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

1. Cornelissen J, Wood A, Sivasothy P, Trull A, Wallwork J. Randomised trial of cyclosporin C0 vs. C2 monitoring in de novo lung transplant recipients: Interim results. Presented at the 25th International Society of Heart and Lung Transplantation, Philadelphia. J Heart Lung Transplantation 2005;24(2S):S81.
2. Cornelissen J, Trull AK, Parameshwar J, Bellm S, Charman S, Wallwork J. Difficulty in managing cyclosporin C2 monitoring in de novo lung transplant recipients. Presented at the 24th International Society of Heart and Lung Transplantation, San Francisco. J Heart Lung Transplantation 2004;23(2S):S139.

Publication citations

Additional files

Editorial Notes