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Evaluation of the cardiovascular risk in renal transplant patients on Ciclosporin A therapy adapted by immune-monitoring compared to standard therapy

A randomized open-label trial to evaluate the cardiovascular risk in stable renal allograft recipients on a ciclosporin A (CsA) based regimen monitored either by residual expression of nuclear factor of activated T-cells (NFAT) – regulated genes or CsA trough levels - CIS-Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003547-21-DE
Enrollment
Unknown
Registered
2012-12-04
Start date
2013-05-31
Completion date
Unknown
Last updated
2015-03-30

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

Conditions

immunosuppression in renal transplantation

Interventions

Trade Name: Sandimmun Optoral Product Name: NA Product Code: NA Pharmaceutical Form: Capsule, soft INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Concentration unit: mg milligram(s) Concentra

Sponsors

Renal Clinic Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female patients = 18 years old. 2. Recipients of deceased or living kidney transplants. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: The comparison of a CsA-based immunosuppression either monitored by CsA trough levels or NFAT-regulated gene expression concerning the cardiovascular risk;Secondary Objective: Compare peripheral blood pressure (systolic, diastolic, and mean) Compare major cardiovascular events (myocardial infarction, apoplexy, peripheral arterial occlusive disease) Compare incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) Compare renal allograft function ;Primary end point(s): Reduced cardiovascular risk assessed by the change in pulse wave velocity ;Timepoint(s) of evaluation of this end point: month 6—

Secondary

MeasureTime frame
Secondary end point(s): blood pressure incidence of hypertension, hyperlipidemia, diabetes incidence of cardiovascular events renal function incidence of acute rejections;Timepoint(s) of evaluation of this end point: month 6—

Countries

Germany

Contacts

Public ContactClinical Trials Information

Renal Clinic Heidelberg (Nephrology Unit, University Hospital Heidelberg)

info@nierenzentrum-heidelberg.com+49622191120

Outcome results

None listed

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