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Copenhagen Acute Renal Complications After Transplantations Study Group

NCT02744872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-10-06

No results posted yet for this study

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.

Conditions

  • Disorder Related to Lung Transplantation

Interventions

DRUG

Felodipine

Felodipine 10 mg once daily or identical placebo

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Bo Feldt-Rasmussen · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • Denmark

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744872 on ClinicalTrials.gov