Everolimus in de Novo Kidney Transplant Recipients

NCT01410448 | Completed Phase 3 Results

• 2 other identifiers: CRAD001AIT252011-002866-19
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Kidney Transplantation

Keywords

Immunosuppression; Kidney transplantation; everolimus; safety

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Without Wound Healing Complications - Worst-case Scenario

  The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.

  3 months

Secondary Outcomes (16)

• Percentage of Participants Without Wound Healing Complications - Worst-case Scenario

  12 months

• Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario

  3 months

• Patient Survival Rate: Percentage of Deaths - Worst-case Scenario

  3 Months, 12 months

• Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario

  3 months

• Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario

  3 months, 12 months

Study Arms (2)

Immediate Everolimus (IE)

ACTIVE COMPARATOR

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.

Drug: Everolimus; Drug: Cyclosporine; Drug: Steroids

Delayed Everolimus

EXPERIMENTAL

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.

Drug: Everolimus; Drug: Mycophenolate sodium; Drug: Cyclosporine; Drug: Steroids

Interventions

Everolimus DRUG

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

Also known as: Certican®

Delayed Everolimus; Immediate Everolimus (IE)

Mycophenolate sodium 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.

Also known as: Myfortic®

Delayed Everolimus

Cyclosporine DRUG

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

Also known as: Neoral®

Delayed Everolimus; Immediate Everolimus (IE)

Steroids DRUG

Steroids were administered according to local clinical practice.

Delayed Everolimus; Immediate Everolimus (IE)

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (22)

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

Coppito, AQ, 67100, Italy

Location

Novartis Investigative Site

Bari, BA, 70124, Italy

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Cagliari, CA, 09134, Italy

Location

Novartis Investigative Site

Catania, CT, 95123, Italy

Location

Novartis Investigative Site

Florence, FI, 50139, Italy

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Palermo, PA, 90127, Italy

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Roma, RM, 00144, Italy

Location

Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Roma, RM, 00161, Italy

Location

Novartis Investigative Site

Roma, RM, 00168, Italy

Location

Novartis Investigative Site

Salerno, SA, 84131, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Verona, VR, 37126, Italy

Location

Novartis Investigative Site

Novara, 28100, Italy

Location

MeSH Terms

Interventions

Everolimus; Mycophenolic Acid; Cyclosporine; Steroids

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Fused-Ring Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 5, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-03

Locations

IT (22)