trial to prevent kidney injury due to side effects of the treatment to prevent rejection of a transplanted lung.

Prospective randomised dubbleblind placebocontrolled trial of calcium antagonist to prevent calcineurin induced nephropathy in lung transplanted patients - CARCATS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004771-22-DK

Enrollment

Registered

2008-07-29

Start date

2008-09-03

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

kidney damage in ciclosporin treated lung transplant patients. MedDRA version: 14.1 Level: PT Classification code 10029155 Term: Nephropathy toxic System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: PT Classification code 10056409 Term: Heart and lung transplant System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10025127 Term: Lung transplant System Organ Class: 10042613 - Surgical and medical pr

Interventions

Product Name: Felodipin Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over the age of 18 and eligible for a lung transplant 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients are excluded if: Treated with calcium channel blocker within 14 days Women in the child bearing age who are not using safe contraception Allgies towoards felodipin

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if Calcium channel blockade protect against kidney damage in ciclosporin treated lung transplant patients. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of the trial is kidney function measured by cr-51-EDTA, there are no secondary endpoints. ;Timepoint(s) of evaluation of this end point: 84 days	—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Denmark

Contacts

Public ContactMartin Iversen

Rigshospitalet

4535453545

Outcome results

None listed

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