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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17970029
Enrollment
90
Registered
2005-07-08
Start date
2003-04-01
Completion date
Unknown
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung transplant recipients Surgery Transplanted organ and tissue status

Interventions

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 adjus

Sponsors

Papworth Hospital NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Renal function at 3 months post transplant

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026