Trials Sponsors Conditions Drugs Pricing

Conditions

Kidney Transplant

Keywords

Kidney transplantrenal transplantimmunosuppressionmycophenolate mofetiltacrolimuseverolimus

Outcome Measures

Primary Outcomes (1)

Number of Participants With Incidence of Composite Efficacy Failure
Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)\*, (2) graft loss\*\*, (3) participant death or(4) loss to follow-up. \*A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. \*\*Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.
12 Months

Secondary Outcomes (6)

Estimated Glomerular Filtration Rate (eGFR)
12 Months
Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)
12 Months
Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy
12 Months
Number of Participants With Incidence of New Onset of Diabetes Mellitus
12 Months
Number of Participants With Incidence of Proteinuria Events
Baseline and 12 Months
+1 more secondary outcomes

Study Arms (2)

Everolimus (EVR) & low dose of tacrolimus

EXPERIMENTAL

Everolimus (EVR) and tacrolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was \< 3 ng/mL, or reduced if the trough level was \> 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.

Drug: Everolimus and tacrolimus

Mycophenolate mofetil & standard dose tacrolimus

ACTIVE COMPARATOR

Mycophenolate mofetil and tacrolimus (MMF) treatment arm: MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. Tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, target level of tacrolimus was reduced to 5 - 8 ng/mL.

Interventions

Everolimus and tacrolimusDrug

Everolimus: * Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets * Dose: 1.5 mg per day * Frequency: 0.75 mg twice daily Tacrolimus: * Dose adjusted to maintain specific blood levels

Everolimus (EVR) & low dose of tacrolimus

mycophenolate mofetil and tacrolimusDrug

Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Everolimus and tacrolimus
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
mycophenolate mofetil and tacrolimus
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female renal recipients 18-70 years of age undergoing kidney transplantation, either primary or re-transplant;
Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death), living unrelated or non-HLA identical living related donor kidney;

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

Study Sites (50)

Novartis Investigative Site

Birmingham, Alabama, 35233, United States

Novartis Investigative Site

Tucson, Arizona, 85742-5022, United States

Novartis Investigative Site

Los Angeles, California, 90033, United States

Novartis Investigative Site

Los Angeles, California, 90048, United States

Novartis Investigative Site

Los Angeles, California, 90095, United States

Novartis Investigative Site

Orange, California, 92868, United States

Novartis Investigative Site

Sacramento, California, 95817, United States

Related Publications (1)

Shihab F, Qazi Y, Mulgaonkar S, McCague K, Patel D, Peddi VR, Shaffer D. Association of Clinical Events With Everolimus Exposure in Kidney Transplant Patients Receiving Low Doses of Tacrolimus. Am J Transplant. 2017 Sep;17(9):2363-2371. doi: 10.1111/ajt.14215. Epub 2017 Mar 4.
PMID: 28141897DERIVED

MeSH Terms

Interventions

EverolimusTacrolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Limitations and Caveats

HLA mismatches ≥3, everolimus group 261 vs MMF group 240

Results Point of Contact

Title: Study Director
Organization: Novartis

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

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

Enrollment

613 participants (actual enrollment reported by the registry).

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

November 19, 2009

First Posted

December 4, 2009

Study Start

January 2010

Date type not reported

This date has not been verified as actual or estimated.

Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Everolimus (EVR) & low dose of tacrolimus

Mycophenolate mofetil & standard dose tacrolimus

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (50)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Everolimus (EVR) & low dose of tacrolimus

Mycophenolate mofetil & standard dose tacrolimus

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (50)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations