Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) - TREAT

• Conditions: Treatment of anemia in subjects with chronic kidney disease (CKD).; MedDRA version: 14.1Level: PTClassification code 10058116Term: Nephrogenic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2004-000134-37-IT
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-21
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

- Before any study-specific procedure, the appropriate informed consent must be obtained (see Section 12.1). - at least 18 years old. - Clinical history of type 2 DM defined as:32 a. hyperglycemia not requiring insulin therapy or, b. hyperglycemia requiring insulin when either i. The period between diagnosis and the initiation of insulin therapy is > 1 year and/or, ii. C-peptide levels are elevated above normal. - Clinical history of CKD (at any point prior to registration) defined as: a. creatinine clearance or eGFR > 20 mL/min and < 60 mL/min or, b. serum creatinine > 1.2 mg/dL for all females, > 1.5 mg/dL for black males, and > 1.3 mg/dL for non-black males. - An eGFR during the screening period > 20 mL/min and < 60 mL/min measured by the following MDRD equation: eGFR = 186 x [Serum creatinine]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black] - Mean Hb < 11.0 g/dL (mean of 2 values taken at least 6 days apart during the screening period, using the hemoglobin point of care device). - Mean Tsat > 15% (mean of 2 values taken at least 6 days apart during the screening period).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Anticipating or scheduled for a living related-donor kidney transplant, or a prior recipient of a kidney transplant. - Uncontrolled hypertension defined as diastolic BP >110 mm Hg or systolic BP > 180 mmHg on 2 separate occasions during screening. - Use of any erythropoietic protein (eg, rHuEPO; Procrit, Eprex, Neorecormon, Epogen, Aranesp) within 12 weeks of randomization. - Prior history (within 12 weeks of randomization) of CV events including: a. Myocardial ischemia b. Hospitalization for CHF c. MI d. CVA - Grand mal seizure within the 12 weeks prior to randomization. - Major surgery within 12 weeks prior to subject randomization (excluding vascular access surgery). - Currently receiving intravenous antibiotic therapy for systemic infection. - Known HIV positive. - Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia. - Currently receiving systemic chemotherapy and/or radiotherapy. - Active bleeding. - Hematologic disease (eg, sickle cell disease, myelodysplastic syndromes, hematologic malignancy); myeloma; hemolytic anemia, thalassemia. - Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational product trial(s), or subject is receiving other investigational agent(s). - Subject is pregnant (eg, positive HCG test) or is breast-feeding. Females must have a negative serum pregnancy test (or definitive evidence to demonstrate lack of pregnancy) within 21 days prior to randomization if they are of childbearing potential, unless there is a documented history of amenorrhea. - Subject is not using adequate contraceptive precautions, as determined by the investigator. - Subject has known sensitivity to any of the products to be administered during dosing. - Subject has previously entered this trial (this does not include subjects who rescreen). - Subject will not be available for follow-up assessments. - Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. Subjects are ineligible for participation in the functional capacity sub-study if (in addition to the above) they: 1. Have intrinsic walking limitations (eg, amputation, stroke) 2. Do not consent to participate in the sub-study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of anemia therapy with darbepoetin alfa on the composite event comprising all-cause mortality and cardiovascular (CV) events (including myocardial ischemia, congestive heart failure [CHF], myocardial infarction [MI], and cerebrovascular accident [CVA]) in subjects with both CKD and type 2 diabetes mellitus (DM).;Secondary Objective: To assess the effect of darbepoetin alfa on the time to end-stage renal disease (ESRD). To assess the effect of anemia therapy with darbepoetin alfa on CV mortality and the individual components of the composite event: all-cause mortality and CV events. To assess the effect of darbepoetin alfa on the change in the rate of decline in glomerular filtration rate (eGFR) and patient-reported fatigue.;Primary end point(s): Primary Endpoint: Time to the composite event comprising all-cause mortality and CV events including: ? Myocardial ischemia ? CHF ? MI ? CVA