Trials Sponsors Conditions Drugs Pricing

Conditions

Kidney Transplantation Cardiovascular Diseases

Keywords

Framingham scorekidney transplantimmunosuppressioncardiovascular diseaseCellCeptmycophenolate mofetil

Outcome Measures

Primary Outcomes (2)

The change in the Framingham 10-yr age and gender adjusted score for coronary heart disease from baseline to Month 6
Baseline to Month 6
The incidence of a composite of acute rejection (clinically suspected and biopsy-proven), graft loss or patient death.
Month 6

Secondary Outcomes (13)

Framingham point total
Baseline to Month 6
Day and night blood pressure
Baseline to Month 6
Glucose metabolism
Baseline to Month 6
Lipid metabolism
Baseline to Month 6
Change in renal function
Baseline to Month 6
+8 more secondary outcomes

Study Arms (2)

CellCept optimization

EXPERIMENTAL

Drug: mycophenolate mofetil

Control

ACTIVE COMPARATOR

Other: standard immunosuppression

Interventions

mycophenolate mofetilDrug

Introduction of CellCept or increase in the dose of CellCept to a maximum of 2 g/day. In patients not already receiving CellCept, azathioprine (AZA), enteric-coated mycophenolate sodium (EC-MPS) or sirolimus (SRL) will be discontinued and replaced by CellCept in divided doses to a maximum of 2 g/day. CNI doses will be reduced to conform to the target trough levels in the low-dose CNI arms of the ELITE-Symphony study +/- steroid dose reduction. Any CNI dose change will require measurement of CNI trough levels at 7 days post dose change +/- 3 days. Target CNI trough levels in the Symphony study: * Low-dose CsA: Initial oral dose of 1-2 mg/kg bid, to achieve a target trough level of 50-100 ng/mL. * Low-dose TAC: Initial oral dose of 0.1 mg/kg/day divided into two doses\* with a target trough level of 3-7 ng/mL (\*Advagraf may also be used at a dose of 0.1 mg/kg once daily with a target trough level of 3-7 ng/mL)

Also known as: CellCept, MMF

CellCept optimization

standard immunosuppression

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Renal transplant recipients who are ≥ 6 months post-day of transplant surgery.
Single organ kidney recipient (may be for first or repeat transplant).

Sponsors & Collaborators

Hoffmann-La Roche
Industrycollaborator
Ramesh Prasad
Otherlead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

Dr. Ramesh Prasad, MBBS MSc
Unity Health Toronto
PRINCIPAL INVESTIGATOR

Enrollment

2 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Staff Nephrologist

Study Record Dates

First Submitted

September 28, 2010

First Posted

October 4, 2010

Study Start

October 2010

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Mycophenolate Mofetil for Reducing Cardiovascular Risk in Renal Transplant Recipients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (13)

Study Arms (2)

CellCept optimization

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

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

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (13)

Study Arms (2)

CellCept optimization

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations