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

NCT01404325 | Completed Phase 3 Results DMC

• 2 other identifiers: CRAD001ADE362011-001539-21
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Lung Transplantation

Keywords

Lung transplantation; everolimus; kidney function; renal function

Outcome Measures

Primary Outcomes (1)

• Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months

  Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)\^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1

  Month 12

Secondary Outcomes (26)

• Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12

  Month 1, 3, 6, 9, 12

• Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12

  Month 1, 3, 6, 9, 12

• Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12

  Month 1, 3, 6, 9, 12

• Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12

  Month 1, 3, 6, 9, 12

• Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12.

  Baseline, Month 6, Month 12

Study Arms (2)

Quadruple low level IS regimen

EXPERIMENTAL

quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids

Drug: Everolimus

Centre specific triple IS regimen

EXPERIMENTAL

centre specific CNI-based triple drug immunosuppression (IS)

Drug: standard therapy

Interventions

standard therapy DRUG

centre specific CNI-based triple drug immunosuppression

Centre specific triple IS regimen

Everolimus DRUG

quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids

Also known as: RAD001

Quadruple low level IS regimen

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Homburg, 66421, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Related Publications (2)

• Kneidinger N, Valtin C, Hettich I, Frye BC, Wald A, Wilkens H, Bessa V, Gottlieb J. Five-year Outcome of an Early Everolimus-based Quadruple Immunosuppression in Lung Transplant Recipients: Follow-up of the 4EVERLUNG Study. Transplantation. 2022 Sep 1;106(9):1867-1874. doi: 10.1097/TP.0000000000004095. Epub 2022 Mar 8.

  PMID: 35283454 DERIVED

• Gottlieb J, Neurohr C, Muller-Quernheim J, Wirtz H, Sill B, Wilkens H, Bessa V, Knosalla C, Porstner M, Capusan C, Struber M. A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation. Am J Transplant. 2019 Jun;19(6):1759-1769. doi: 10.1111/ajt.15251. Epub 2019 Feb 5.

  PMID: 30615259 DERIVED

MeSH Terms

Interventions

Standard of Care; Everolimus

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

8627788300

Study Officials

• Novartis Pharmceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 28, 2011
• Study Start: February 1, 2012
• Primary Completion: January 5, 2017
• Study Completion: January 5, 2017
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2018-11

Locations

DE (9)