Randomised trial to compare the clinical value of cyclosporin C12 and C2 monitoring after lung transplantation

ISRCTN	ISRCTN17970029
DOI	https://doi.org/10.1186/ISRCTN17970029
Protocol serial number	P00784
Sponsor	Papworth Hospital NHS Trust (UK)
Funder	Novartis Pharmaceuticals (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Pasupathy Sivasothy
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised trial to compare the clinical value of cyclosporin C12 and C2 monitoring after lung transplantation
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Renal function at 3 months post transplant
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	90
Key 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
Key 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
Date of first enrolment	01/04/2003
Date of final enrolment	01/04/2006

Transplant Unit

Papworth Everard
CB3 8RE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	results presented at 24th International Society of Heart and Lung Transplantation	01/02/2004		No	No
Abstract results	results presented at 25th International Society of Heart and Lung Transplantation	01/02/2005		No	No

05/07/2018: Internal review