Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT) - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00093015

Purpose

The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa on mortality and cardiovascular morbidity in patients with chronic kidney disease and type 2 diabetes.

Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD

Condition	Intervention	Phase
Kidney Disease Diabetes Mellitus Anemia	Drug: Placebo Drug: darbepoetin alfa	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Trial to Reduce Cardiovascular Events With Aranesp® Therapy

Resource links provided by NLM:

MedlinePlus related topics: Anemia Diabetes

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Time to all-cause mortality or ESRD, with overall alpha spent of 0.002 [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Time to all-cause mortality or cardiovascular events (MI, CHF, CVA, Myocardial ischemia), with overall alpha spent of 0.048 [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to all-cause mortality [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Time to cardiovascular mortality [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Time to MI [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Time to CVA [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Time to CHF [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Time to ESRD [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Rate of decline in eGFR relative to baseline [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Change in patient reported fatigue relative to baseline at week 25 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Time to myocardial ischemia [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4000
Study Start Date:	August 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Active Comparator	Drug: darbepoetin alfa Starting dose : 0.75 mcg/kg SC Q2W; subsequent doses titrated to achieve Hb target of 13.0 g/dL
Placebo: Placebo Comparator	Drug: Placebo Volume and dose frequency changes resembling dosing in the active treatment group

Eligibility

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

Criteria

Inclusion Criteria: - Hemoglobin less than or equal to 11 g/dL - History of Chronic Kidney Disease - eGFR greater than or equal to 20 mL/min and less than or equal to 60 mL/min - Tsat greater than 15% Exclusion Criteria: - Uncontrolled hypertension - Erythropoietic protein use within 12 weeks of randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093015

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Mix TC, Brenner RM, Cooper ME, de Zeeuw D, Ivanovich P, Levey AS, McGill JB, McMurray JJ, Parfrey PS, Parving HH, Pereira BJ, Remuzzi G, Singh AK, Solomon SD, Stehman-Breen C, Toto RD, Pfeffer MA. Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease. Am Heart J. 2005 Mar;149(3):408-13.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill J, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R, Uno H; TREAT Investigators. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). Am J Kidney Dis. 2009 Jul;54(1):59-69. Epub 2009 Jun 5.

Pfeffer MA; TREAT Executive Committee. An ongoing study of anemia correction in chronic kidney disease. N Engl J Med. 2007 Mar 1;356(9):959-61. No abstract available.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010184, TREAT
Study First Received:	September 28, 2004
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00093015 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Urologic Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Darbepoetin alfa

Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009