Copenhagen Acute Renal Complications After Transplantations Study Group

NCT02744872 | Completed Phase 4 DMC

• 1 other identifier: 2008-004771-22
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder Related to Lung Transplantation

Keywords

lung transplantation; chronic renal insufficiency

Outcome Measures

Primary Outcomes (1)

• Change in glomerular filtration rate

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

  week 1, 2, 3 and 12

Study Arms (2)

Felodipine

ACTIVE COMPARATOR

Tablet Felodipin 10 mg x 1 daily

Drug: Felodipine

Placebo

PLACEBO COMPARATOR

Identical placebo once daily

Drug: Placebo

Interventions

Felodipine DRUG

Felodipine 10 mg once daily or identical placebo

Felodipine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who are undergoing lung transplantation in Denmark

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet

Copenhagen Ø, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Felodipine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bo Feldt-Rasmussen

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 20, 2016
• Study Start: September 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2016-10

Locations

DK (1)