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Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients

A 2-arm, Prospective, Randomized, Controlled, Open-label, 12 Month Phase III Trial to Evaluate the Efficacy Regarding Renal Function of Everolimus in Combination With a Centre Specific Standard Immunosuppressive Regimen Consisting of CNI, Purinantagonists and Steroids Versus a Standard Triple Immunosuppressive Regimen in Lung Transplant Recipients.

NCT01404325•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment

Exclusion Criteria

•Patients with thrombocytopenia (platelets \<100,000/mm³), with an absolute neutrophil count of \<1,500/mm³ or leucopenia (leucocytes \<3000/mm³), with anemia with Hb \< 8g/dl at time of screening
•Patients with uncontrolled hypercholesterolemia (\> 350 mg/dL; \> 9.1 mmol/L) or hypertriglyceridemia (\> 750 mg/dL; \> 8.5 mmol/L) at time of screening

Locations (9)

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Freiburg im Breisgau, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Hanover, Germany

Novartis Investigative Site

Homburg, Germany

Novartis Investigative Site

Leipzig, Germany

Novartis Investigative Site

München, Germany

Key Dates

Start Date

February 1, 2012

Primary Completion Date

January 5, 2017

Completion Date

January 5, 2017

Last Updated

March 14, 2019

Enrollment

130

ACTUAL participants

Conditions

Lung Transplantation

Interventions

standard therapy

DRUG

Everolimus

DRUG

Trifecta-Lung cfDNA-MMDx Study

NCT05837663

Lung Transplantation

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RECRUITING

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

NCT07291258

Solid Organ TransplantationPregnancy+11 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients

Inclusion Criteria

Exclusion Criteria

Trifecta-Lung cfDNA-MMDx Study

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation

LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation

Sleep-disordered Breathing After Solid Organ Transplantation