Correction Study of R744 in Renal Anemia Patients on Hemodialysis

NCT00433693 | Completed Phase 3

• 1 other identifier: JH20562
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.

Conditions

Hemodialysis Patients

Outcome Measures

Primary Outcomes (1)

• The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL

  26 weeks

Secondary Outcomes (10)

• Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL

  26 weeks

• Regression line of Hb concentration per week

  26 weeks

• Achievement rate of Hb concentration of ≥ 11.0 g/dL

  26 weeks

• Transition of Hb concentration

  26 weeks

• dose transition of study drug

  26 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: R744

Interventions

R744 DRUG

50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25\~300μg(i.v.)/4 week

Also known as: methoxy polyethylene glycol-epoetin beta

1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been receiving hemodialysis more than 1 time a week
• Patients aged ≥ 20 years at the time of obtaining consent
• After starting of hemodialysis, patients who have not received rHuEPO preparation
• After starting of hemodialysis, patients whose value of Hb concentrations determined before the first hemodialysis during the last week prior to the registration has been \< 10.0 g/dL

You may not qualify if:

• Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions after starting of hemodialysis during the last week before registration)
• Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
• Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure during the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug
• Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
• Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)
• Patients hypersensitive to a rHuEPO preparation
• Patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage
• Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration
• Patients who have received another investigational drug within 12 weeks before registration
• Patients who have received R744 before registration
• Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration
• Patients who have received erythrocyte transfusion within 16 weeks before registration
• Patients for whom a surgical operation involved with heavy bleeding is planned during the study period
• In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (6)

Chugoku/Shikoku region

Chugoku/Shikoku, Japan

Location

Chubu region

Chūbu, Japan

Location

Hokkaido/Tohoku region

Hokkaido/Tohoku, Japan

Location

Kanto/Koshinetsu region

Kanto/Koshinetsu, Japan

Location

Kinki/Hokuriku region

Kinki/Hokuriku, Japan

Location

Kyusyu region

Kyusyu, Japan

Location

MeSH Terms

Interventions

continuous erythropoietin receptor activator

Study Officials

• Takanori Baba

  Clinical Research Department 2

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 12, 2007
• Study Start: February 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

JP (6)