Clinical Study of R744 to Predialysis Patients

NCT00433615 | Completed Phase 3

• 1 other identifier: JH20566
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Anemia in Pre-Dialysis Patients

Outcome Measures

Primary Outcomes (1)

• Ratio of Maintenance of target Hb concentration

  24th and 48th week

Secondary Outcomes (7)

• Slope of regression line of Hb concentration (g/dL/week)

  24th week

• Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL

  24th week

• Ratio of Maintenance of Hb concentration

  24th and 48th week

• Adverse events

  24th and 48th week

• Laboratory measurements

  24th and 48th week

Study Arms (2)

1

EXPERIMENTAL

Drug: R744

2

EXPERIMENTAL

Drug: R744

Interventions

R744 DRUG

100μg(s.c./i.v.)/4 week for 8 weeks, then 25\~400μg(s.c./i.v.)/4 week for 40 weeks

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 whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≥ 30 mL /min at any one time point within 12 weeks before registration
• Patients aged ≥ 20 years at the time of obtaining consent
• Patients who have been receiving a rHuEPO preparation at least once a month for at least 8 weeks before registration
• Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between ≥ 10.0 g/dL and \<13.0 g/dL
• Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any one time point within 8 weeks before registration

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 within 12 weeks 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 in 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 who are applicable to the following criteria ⅰ), ⅱ), ⅲ), and whose mean value of Hb concentrations determined within 8 weeks before registration has been \> 12.0 g/dL
• ⅰ)Patients with an anamnesis of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
• ⅱ)Patients with complication of unstable angina pectoris or controlled angina pectoris (hardly controlled regardless of drug treatment or interventional treatment )
• ⅲ)Patients with congestive cardiac failure (≥ Class II in Fontaine arteriosclerosis obliterans classification)
• 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

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: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

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

Record last verified: 2009-01

Locations

JP (6)