CARCATS: Copenhagen Acute Renal Complications After Transplantations Study Group

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT02744872

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lung transplanted patients experience marked decrease in renal function post transplant mainly due to cyclosporine induced renal changes. Calcium channel blockers may improve renal function in cyclosporine treated transplant recipients through their effects in avoiding cyclosporine-induced renal vasoconstriction and facilitating renal sodium output.

The aim of this study is to examine if calcium channel blockade administered before lung transplantation prevent cyclosporine induced nephropathy.

The design is an intention to treat randomized double blinded single center study. Patients are randomized to two groups, one that received felodipine and one that receives placebo.

Study population is all patients listed for lung transplantation in Denmark in the study period.

Intervention is tablet felodipine titrated to 10 mg, one daily dose in 12 weeks

Primary endpoint is change in renal function as measured by glomerular filtration rate using chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) in the felodipine treated group compared with the placebo group.

Condition or Disease	Intervention/Treatment	Phase
Disorder Related to Lung Transplantation	Drug: Felodipine Drug: Placebo	Phase 4

Detailed Description

Lung transplanted patients experience marked decrease in renal function post transplant mainly due to cyclosporine induced renal changes.

Calcium channel blockers exert renal effects consisting mainly of renal vasodilation and facilitation of renal excretion of sodium through a direct action on renal tubules. Calcium channel blockers improve renal function in cyclosporine treated transplant recipients through their effects in avoiding cyclosporine-induced renal vasoconstriction and facilitating renal sodium output.

Studies in both animal models and humans have demonstrated that calcium channel blockers maintain or reduce renal vascular resistance and preserve or enhance renal blood flow and glomerular filtration rate (GFR).

The aim of this study is to examine if calcium channel blockade administered before lung transplantation prevent cyclosporine induced nephropathy.

The design is an intention to treat randomized double blinded single center study. Patients are randomized to two groups, one that received felodipine and one that receives placebo.

Study population is all patients listed for lung transplantation in Denmark in the study period.

Sample size calculation estimated that 32 patients are needed, 16 patients in each group, with an estimated dropout incidence of 5 patients in each group. This will be able to detect an estimated 50% reduction in the decrease in measured GFR from 40 ml/min in the placebo group to 20 ml/min in treatment group, 80% power and a two-sided t-test, 5 % significance level.

Intervention is tablet Felodipine titrated to 10 mg, one daily dose in 12 weeks

Renal function is determined by 51-Cr-EDTA clearance measurement at times 0 before transplantation and after 1, 3 and 12 weeks.

Primary endpoint is change in renal function as measured by 51-Cr-EDTA clearance in the felodipine treated group compared with the placebo group.

Safety is monitored and adverse events are usually mild headache, tachycardia, leg edema, angina pectoris and hypotension.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Prospektivt Randomiseret Dobbeltblindt Placebo-kontrolleret Studie af, Calciumkanalblokade påbegyndt Inden Operation: Med Henblik på at Forebygge Ciclosporin Induceret Nefropati Efter Lungetransplantation

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Felodipine Tablet Felodipin 10 mg x 1 daily	Drug: Felodipine Felodipine 10 mg once daily or identical placebo
Placebo Comparator: Placebo Identical placebo once daily	Drug: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: Felodipine

Tablet Felodipin 10 mg x 1 daily

Drug: Felodipine

Felodipine 10 mg once daily or identical placebo

Placebo Comparator: Placebo

Identical placebo once daily

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Change in glomerular filtration rate [week 1, 2, 3 and 12]
glomerular filtration rate using chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) at week 1, 2, 3 and 12

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients who are undergoing lung transplantation in Denmark

Exclusion Criteria:

Fertile women not using contraceptives
Patients allergic to calcium antagonists
Patients receiving treatment with Calcium antagonist 14 days prior to transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet	Copenhagen Ø	Copenhagen	Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator: Bo Feldt-Rasmussen, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bo Feldt-Rasmussen, Professor, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT02744872

Other Study ID Numbers:

2008-004771-22

First Posted:

Apr 20, 2016

Last Update Posted:

Oct 6, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Bo Feldt-Rasmussen, Professor, Rigshospitalet, Denmark

lung transplantation

chronic renal insufficiency

Additional relevant MeSH terms:

Felodipine

Study Results

No Results Posted as of Oct 6, 2016