Dynepo Infrequent Dosing Study

Shire

Status and phase: Terminated; Phase 3

Conditions: Kidney Failure; Anemia

Treatments: Drug: Dynepo; Drug: Dynepo (Epoetin delta)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450333

SPD490-301

2006-002052-15 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).
• Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
• Transferrin saturation >= 20% and ferritin >= 100 ng/mL.

Exclusion criteria

• Uncontrolled hypertension.
• Requiring doses of EPO > 10,000 IU/week.
• Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
• Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
• Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
• Androgen therapy in the 30 days immediately prior to randomisation in the study.
• Known Human Immunodeficiency Virus(HIV)infection.
• History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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407 participants in 4 patient groups

1

Active Comparator group

Description:

Erythropoietin(EPO)-naive BIW

Treatment:

Drug: Dynepo (Epoetin delta)

2

Active Comparator group

Description:

EPO-naive QW

Treatment:

Drug: Dynepo

Drug: Dynepo

Drug: Dynepo

3

Active Comparator group

Description:

EPO QW

Treatment:

Drug: Dynepo

Drug: Dynepo

Drug: Dynepo

4

Active Comparator group

Description:

EPO Q2W

Treatment:

Drug: Dynepo

Drug: Dynepo

Drug: Dynepo