Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)

NCT ID: NCT00492427

Last Updated: 2009-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-11-30

Brief Summary

This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.

Conditions

Predialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Group Type: ACTIVE_COMPARATOR

Epoetin beta

Intervention Type: DRUG

6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k\~12000IU(s.c.)/2week for 24\~26weeks in total.

1

Group Type: EXPERIMENTAL

R744

Intervention Type: DRUG

25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25\~250μg(s.c.)/4week for 24\~26weeks in total.

Interventions

R744

25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25\~250μg(s.c.)/4week for 24\~26weeks in total.

Intervention Type: DRUG

Epoetin beta

6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k\~12000IU(s.c.)/2week for 24\~26weeks in total.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 not receiving a rHuEPO preparation at least 16 weeks before registration
• Patients whose value of Hb concentrations determined the nearest week before registration has been < 10.0 g/dL
• Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any time point within 8 weeks before registration

Exclusion Criteria

• 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 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 accompanied by marked bleeding is planned during the study period
• In addition, patients who are judged as ineligible to participate in this study by the investigator or subinvestigator

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chugai Pharmaceutical

Principal Investigators

Takanori Baba

Role: STUDY_CHAIR

Chugai Pharmaceutical,Clinical Research Department 2

Locations

Chugoku/Shikoku region

Chugoku/Shikoku, , Japan

Chubu region

Chūbu, , Japan

Hokkaido/Tohoku region

Hokkaido/Tohoku, , Japan

Kanto/Koshinetsu region

Kanto/Koshinetsu, , Japan

Kinki/Hokuriku region

Kinki/Hokuriku, , Japan

Kyusyu region

Kyusyu, , Japan

Countries

Japan

References

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type: DERIVED

PMID: 36791280 (View on PubMed)

Other Identifiers

JH20565

Identifier Type: -

Identifier Source: org_study_id