Trial to Reduce Cardiovascular Events with Aranesp Therapy - TREAT

• Conditions: Treatment of anaemia in subjects with chronic kidney disease (CKD) and Type 2 diabetes mellitus (DM); MedDRA version: 6.1Level: PTClassification code 10038444

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-11
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Before any study-specific procedure, the appropriate informed consent must be obtained
2. = 18 years old.
3. Clinical history of type 2 DM defined as: hyperglycemia not requiring insulin therapy or, hyperglycemia requiring insulin when either the period between diagnosis and the initiation of insulin therapy is >1 year and/or, C-peptide levels are elevated above normal.
4. Clinical history of CKD (at any point prior to registration) defined as: creatinine clearance or eGFR = 20 mL/min and = 60 mL/min or, 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.
5. 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].
6. 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).
7. 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:
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

1. Anticipating or scheduled for a living related-donor kidney transplant, or a prior recipient of a kidney transplant.
2. Uncontrolled hypertension defined as diastolic BP >110 mm Hg or systolic BP > 180 mmHg on 2 separate occasions during screening.
3. Use of any erythropoietic protein (eg, rHuEPO; Procrit®, Eprex®, Neorecormon®, Epogen®, Aranesp®) within 12 weeks of randomization.
4. Prior history (within 12 weeks of randomization) of CV events including: Myocardial ischemia, Hospitalization for CHF, MI, CVA.
5. Grand mal seizure within the 12 weeks prior to randomization.
6. Major surgery within 12 weeks prior to subject randomization (excluding vascular access surgery).
7. Currently receiving intravenous antibiotic therapy for systemic infection.
8. Known HIV positive.
9. Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
10. Currently receiving systemic chemotherapy and/or radiotherapy.
11. Active bleeding.
12. Hematologic disease (eg, sickle cell disease, myelodysplastic syndromes, hematologic malignancy); myeloma; hemolytic anemia, thalassemia.
13. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational drug trial(s), or subject is receiving other investigational agent(s).
14. 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.
15. Subject is not using adequate contraceptive precautions, as determined by the investigator.
16. Subject has known sensitivity to any of the products to be administered during dosing.
17. Subject has previously entered this trial (this does not include subjects who rescreen).
18. Subject will not be available for follow-up assessments.
19. 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
20. Subjects are ineligible for participation in the functional capacity sub-study if (in addition to the above) they:
a. Have intrinsic walking limitations (eg. amputation, stroke)
b. Do not consent to participate in the sub-study

Study & Design

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