Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts - Full Text View

Sponsor:	Astellas Pharma Inc
Collaborator:	Astellas Pharma Canada, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00933231

Purpose

This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Advagraf Biological: Simulect Drug: Cellcept Drug: Corticosteroids Drug: Ramipril Drug: Irbesartan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Kidney Transplantation

Drug Information available for: Ramipril Methylprednisolone Tacrolimus anhydrous Tacrolimus Irbesartan Basiliximab Corticosteroids

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

The incidence of allograft interstitial fibrosis and tubular atrophy (IF/TA) as assessed at a central pathology lab [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The incidence of allograft IF/TA between 6 and 24 months as assessed at a central pathology lab [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
Renal function will be evaluated by estimation of GFR, serum creatinine, and urine protein:creatinine ratio [ Time Frame: 1, 3, 6, 12 months and annually thereafter ] [ Designated as safety issue: No ]
Blood pressure and the use of antihypertensive agents will be evaluated [ Time Frame: 1, 3, 6, 12 months and annually thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	June 2009
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Standard dose Advagraf with ACEi/ARB: Active Comparator	Drug: Advagraf Standard dose, Oral Biological: Simulect IV Drug: Cellcept Oral Drug: Corticosteroids IV and Oral Drug: Ramipril Oral Drug: Irbesartan Oral
Standard dose Advagraf without ACEi/ARB: Active Comparator	Drug: Advagraf Standard dose, Oral Biological: Simulect IV Drug: Cellcept Oral Drug: Corticosteroids IV and Oral
Low-dose Advagraf with ACEi/ARB: Experimental	Drug: Advagraf Low dose, Oral Biological: Simulect IV Drug: Cellcept Oral Drug: Corticosteroids IV and Oral Drug: Ramipril Oral Drug: Irbesartan Oral
Low-dose Advagraf without ACEi/ARB: Experimental	Drug: Advagraf Low dose, Oral Biological: Simulect IV Drug: Cellcept Oral Drug: Corticosteroids IV and Oral

Detailed Description:

The study will consist of the following 4 treatment groups.:

Standard Advagraf dose with angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) antihypertensive therapy
Standard Advagraf dose without ACEi/ARB antihypertensive therapy
Low dose Advagraf with ACEi/ARB antihypertensive therapy
Lose dose Advagraf without ACEi/ARB antihypertensive therapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is the recipient of a first or second deceased or living donor mismatched (at least one mismatch) renal transplant
If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
Recipient of a kidney from a donor over 65 years of age
Recipient of non-related donor kidney with peak pre-transplant Panel Reactive Antibodies >50
Presence of donor specific antibody as detected by solid phase methodology
Subject who has lost a previous graft for immunological reasons less than one year from transplant
Subject is pregnant or breastfeeding
Subject receives a kidney lacking pre-implantation biopsy
Subject has significant disease (e.g. malignancy or uncontrolled infection) or disability (e.g. cognitive defect) which prevents understanding of, or adherence to the protocol
Subjects who in the opinion of the Investigator, require ACEi/ARB therapy post-transplant for any indication
Subjects requiring induction with Thymoglobulin, Campath, antithymocyte globulin (ATG), antilymphocyte globulin (ALG) or any other biological induction agent other than basiliximab
Subject has plans to become pregnant within 2 years post-transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933231

Contacts

Contact: Astellas Pharma Canada Inc., Medical Information

888-338-1824

Locations

Canada
	Recruiting
Quebec, Canada, G1R 2J6
Canada, Alberta
	Recruiting
Edmonton, Alberta, Canada, T6G 2G3
	Recruiting
Calgary, Alberta, Canada, T2N 2T9
Canada, Manitoba
	Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
	Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
	Not yet recruiting
London, Ontario, Canada, N6A 5A5
Canada, Quebec
	Recruiting
Montreal, Quebec, Canada, H3A 1A1
	Recruiting
Montreal, Quebec, Canada, H2L 4M1
	Recruiting
Montreal, Quebec, Canada, H1T 2M4
	Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
	Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7V 0Z9

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Canada, Inc.

Investigators

Study Director:

Use Central Contact

Astellas Pharma Canada, Inc.

More Information

No publications provided

Responsible Party:	Astellas Pharma Global Development ( Sr. Mgr. Clinical Trials Registry )
Study ID Numbers:	FKC-014
Study First Received:	July 2, 2009
Last Updated:	December 2, 2009
ClinicalTrials.gov Identifier:	NCT00933231 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

Kidney Transplantation
Tacrolimus
Angiotensin-Converting Enzyme Inhibitors
Advagraf
Immunosuppression

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Methylprednisolone
Physiological Effects of Drugs
Irbesartan
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Tacrolimus
Neuroprotective Agents
Hormones
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors

Gastrointestinal Agents
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010