Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients

Phase 1

• Conditions: Anemia in CKD patients not on dialysis; MedDRA version: 18.1Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-005180-27-BE
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-21
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Subject is eligible for the study if all of the following apply:
- Age = 18 years
- Diagnosis of chronic kidney disease, with Kidney Disease Outcomes
Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with
an eGFR <60 mL/min/1.73 m2 estimated using the abbreviated 4-
variable Modification of Diet in Renal Disease (MDRD) equation.
- Mean of the three most recent Hb values during the Screening period,
obtained at least 4 days apart, must be =10.0 g/dL, with a difference of
=1.0 g/dL between the highest and the lowest values.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =3
x upper limit of normal (ULN), and total bilirubin (TBL) =1.5 x ULN.
- Body weight of 45.0 kg up to a maximum of 160.0 kg.

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 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Subject will be excluded from participation if any of the following apply:
- Any ESA treatment within 12 weeks prior to randomization.
- More than one dose of IV iron within 12 weeks prior to randomization.
- RBC transfusion within 8 weeks prior to randomization.
- Chronic inflammatory disease that could impact erythropoiesis.
- Myocardial infarction, acute coronary syndrome, stroke, seizure, or a
thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12
weeks prior to randomization.
- Two or more blood pressure values of systolic BP=150 mmHg or
diastolic BP=95mmHg within 2 weeks prior to randomization.

Study & Design

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