Maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment versus BAY 85-3934

• Conditions: Anaemia of Chronic Kidney Disease; MedDRA version: 18.0Level: LLTClassification code 10058132Term: Renal anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-001192-21-PL
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-11
• Last Update Posted: 1 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- Male or female subjects = 18 years of age with anemia of chronic kidney disease (CKD) at screening

- Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease or the formula according to Matsuo, et al.)

- Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)

- Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8 weeks prior to randomization

- At least one kidney

- Mean screening Hb concentration of 9.0 to 12.0 g/dL, inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken = 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL, AND all measurements must come from the same local laboratory for any given subject, AND the difference between the lowest level and the highest level is = 1.2 g/dL). Re-screening of subjects who fail the Hb inclusion criterion is allowed only once with a minimum of 4 weeks after the initial screen.
Note: The intention is that Hb measurements will be taken 5 to 7 days apart, but 2 days apart is the minimum.

- Serum ferritin levels = 100 µg/L and < 1,000 µg/L OR transferrin saturation = 20% at screening. Re-screening of subjects is allowed only once. Iron substitution is allowed.

- Folate and vitamin B12 values above the lower limit of normal. Rescreening of subjects who fail the folate and vitamin B12 inclusion criterion is allowed only once with a minimum of 4 weeks after the initial screen.

- Infertile male subjects or men who agree to use adequate contraception when sexually active or women without childbearing potential
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Active hemolysis or diagnosis of hemolytic syndrome
- History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure red-cell aplasia (PRCA)
- History of hemosiderosis or hemochromatosis
- Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
- Aplastic anemia
- Chronic lymphoproliferative diseases
- Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that is likely to require invasive treatment (intraocular injections or laser photocoagulation) during the study
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Uncontrolled and symptomatic hyperparathyroidism
- Uncontrolled active infection
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
- Any allograft (including renal allograft) in place and on immunosuppressive therapy or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit
- Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP = 180/110 mmHg or systolic BP < 95 mmHg, respectively
- Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter,
prolonged QT > 500 msec, third degree atrioventricular [AV] block if not treated with a
pacemaker)

Study & Design

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