Phase 4
N=282
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
Disorder Related to Cardiac Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00377962 ↗Enrolled (actual)
282
Serious AEs
38.3%
Results posted
Apr 2011
Primary outcome: Primary: Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 — 48.6; 48.0; 53.2; 47.5 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (Drug); Mycophenolic acid (MPA)/azathioprine (AZA) (Drug); Calcineurin inhibitors (CNI) (Drug); Steroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 |
48.6; 48.0; 53.2; 47.5; 4.6; -0.5 | — |
| SECONDARY Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24) |
49.3; 49.1; 52.5; 46.8; 3.2; -2.4 | — |
| SECONDARY Change in Serum Creatinine From Baseline to End of Study (Month 24) |
126; 129; 126; 132; 0; 3 | — |
| SECONDARY Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24) |
6; 5 | — |
| SECONDARY Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24) |
3; 0; 0; 0 | — |
| SECONDARY Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24) |
0; 2 | — |
| SECONDARY Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup |
-0.2; -0.1 | — |
| SECONDARY Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup |
-0.2; -0.1 | — |
| SECONDARY Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup |
-0.1; -0.0; 0.1; 0.1; -0.4; -0.1 | — |
| SECONDARY Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup |
-0.6; 0.1; 0; 0 | — |
| SECONDARY Mean Days of Hospitalization From Baseline to End of Study (Month 24) |
8.5; 16.2 | — |
| SECONDARY Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24) |
8; 0; 2; 0; 1; 0 | — |
Summary
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
Eligibility Criteria
Inclusion criteria
- Patients who have undergone a heart or lung transplantation more than 12 months ago.
- Patients receiving Neoral® or Prograf®.
- Patients with a measured or calculated glomerular filtration rate (GFR) > 20 and 60 and 10% above the GFR level at the time of inclusion.
- Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months.
- Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
Exclusion criteria
- Patients who are recipients of multiple organ transplants.
- Patients with measured GFR 70 mL/min/1.73m^2.
- Patients with a treated acute rejection episode within the last 3 months.
- Patients with a platelet count of < 50,000/mm^3 or with a white blood cell count of ≤ 2,500/mm^3 or with a hemoglobin value < 8 g/dL.
- Presence of severe hypercholesterolemia (≥ 8.0 mmol/L) or hypertriglyceridemia (≥ 6.0 mmol/L) despite conventional lipid lowering treatment.
- Patients currently treated or who have been treated with a mammalian target of rapamycin (mTOR) inhibitor.
- Patients who have received an investigational drug within 4 weeks.
- Patients who are human immunodeficiency virus positive or who have a current severe systemic infection requiring continued therapy according to investigator judgment.
- Present use of any immunosuppressive drugs other than Neoral®/Prograf®, mycophenolic acid/azathioprine (MPA/AZA), and/or steroids.
- Patients with a known hypersensitivity to drugs similar to everolimus.
- Symptoms of significant mental illness which, in the opinion of the investigator, may interfere with the patient's ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
- Inability to cooperate or communicate with the investigator.
- Patients with any past (within the last 5 years) or present malignancy other than excised squamous or basal cell carcinoma.
- Females of childbearing potential that are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.
- Patients with a planned coronary revascularization or patients who have experienced a major adverse cardiovascular event (MACE) within the last 3 months.
Data sourced from ClinicalTrials.gov (NCT00377962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.