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Copenhagen Acute Renal Complications After Transplantations Study Group (CARCATS)

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ClinicalTrials.gov Identifier: NCT02744872
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Bo Feldt-Rasmussen, Rigshospitalet, Denmark

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Felodipine

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




Primary Outcome Measures :
  1. Change in glomerular filtration rate [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744872


Locations
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Denmark
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Copenhagen Ø, Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Bo Feldt-Rasmussen Professor
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Responsible Party: Bo Feldt-Rasmussen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02744872    
Other Study ID Numbers: 2008-004771-22
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bo Feldt-Rasmussen, Rigshospitalet, Denmark:
lung transplantation
chronic renal insufficiency
Additional relevant MeSH terms:
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Felodipine
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents