Phase 3
N=802
Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00514514 ↗Enrolled (actual)
802
Serious AEs
52.9%
Results posted
Jan 2017
Primary outcome: Primary: GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen — 63.03; 68.59; 63.08 ml/min/1.73m² — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Everolimus (Drug); Myfortic (Drug); Sandimmun Optoral (Drug); Simulect® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen |
63.03; 68.59; 63.08 | < 0.0001 sig |
| SECONDARY GFR Via Nankivell Formula at Month 12 - All Regimens |
63.03; 68.59; 63.08 | — |
| SECONDARY GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method |
50.23; 56.36; 50.24 | — |
| SECONDARY GFR at Month 12 Utilizing Cockcroft-Gault Formula |
60.18; 64.87; 61.16 | — |
| SECONDARY Mean Change in Serum Creatinine From Month 3 to Month 12 |
1.66; 1.58; 1.76 | — |
| SECONDARY Efficacy Event Data From Baseline 2 (Month 3) to Month 6 |
6; 15; 10; 0; 1; 1 | — |
| SECONDARY Efficacy Event Data Baseline 2 (Month 3) to Month 12 |
13; 20; 13; 1; 2; 1 | — |
| SECONDARY Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk) |
10.9; 10.2; 9.5; 10.3; 8.8; 9.3 | — |
| SECONDARY GFR Calculated Via Nankivell Formula at Month 60 |
60.24; 66.98; 58.74 | — |
| SECONDARY GFR at Month 60 Utilizing Cockcroft-Gault Formula |
55.92; 61.6; 52.91 | — |
| SECONDARY GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method |
47.56; 53.41; 44.79 | — |
| SECONDARY Mean Change in Serum Creatinine From Month 3 to Month 60 |
1.94; 1.69; 2.01 | — |
| SECONDARY Efficacy Event Data After Month 12 to Month 60 |
13; 13; 12; 7; 7; 3 | — |
Summary
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.
Eligibility Criteria
Inclusion criteria
- Males or females, aged 18 - 70 years
- Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
Exclusion criteria
- More than one previous renal transplantation
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Patients receiving a kidney from a non-heart beating donor
- Donor age: 70 years
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00514514). 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.