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Everolimus in de Novo Kidney Transplant Recipients

NCT ID: NCT01410448

Last Updated: 2017-06-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate Everolimus (IE)

Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.

Cyclosporine

Intervention Type DRUG

Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.

Steroids

Intervention Type DRUG

Steroids were administered according to local clinical practice.

Delayed Everolimus

The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.

Mycophenolate sodium

Intervention Type DRUG

Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.

Cyclosporine

Intervention Type DRUG

Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.

Steroids

Intervention Type DRUG

Steroids were administered according to local clinical practice.

Interventions

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Everolimus

Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.

Intervention Type DRUG

Mycophenolate sodium

Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.

Intervention Type DRUG

Cyclosporine

Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.

Intervention Type DRUG

Steroids

Steroids were administered according to local clinical practice.

Intervention Type DRUG

Other Intervention Names

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Certican® Myfortic® Neoral®

Eligibility Criteria

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Inclusion Criteria

* Patients who are willing and able to participate in the study and who provide written informed consent before performing any study related procedure;
* Men or women ≥18 years at transplant;
* Recipients of 1st or 2nd single kidney transplant from deceased donor or living unrelated/related donor \> 14 years;

Exclusion Criteria

* Patients who are recipients of multiple organs transplant, including two kidneys;
* Historical or current peak PRA \> 50%. Patients with already existing antibodies against the donor;
* Thrombocytopenia (platelets \< 75,000/mm³), absolute neutrophil count \<1,500/mm³, leucopenia (leucocytes \< 2,500/mm³) or hemoglobin \< 7 g/dL;
* Body mass index (BMI) \> 30 Kg/m2;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Ancona, AN, Italy

Site Status

Novartis Investigative Site

Coppito, AQ, Italy

Site Status

Novartis Investigative Site

Bari, BA, Italy

Site Status

Novartis Investigative Site

Bologna, BO, Italy

Site Status

Novartis Investigative Site

Brescia, BS, Italy

Site Status

Novartis Investigative Site

Cagliari, CA, Italy

Site Status

Novartis Investigative Site

Catania, CT, Italy

Site Status

Novartis Investigative Site

Florence, FI, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Modena, MO, Italy

Site Status

Novartis Investigative Site

Palermo, PA, Italy

Site Status

Novartis Investigative Site

Padua, PD, Italy

Site Status

Novartis Investigative Site

Pavia, PV, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Salerno, SA, Italy

Site Status

Novartis Investigative Site

Siena, SI, Italy

Site Status

Novartis Investigative Site

Verona, VR, Italy

Site Status

Novartis Investigative Site

Novara, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2011-002866-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001AIT25

Identifier Type: -

Identifier Source: org_study_id

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