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

NCT00492427 | Completed Phase 3 DMC

• 1 other identifier: JH20565
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL

  26 weeks

Secondary Outcomes (10)

• Mean Hb concentration for term of evaluation

  26 weeks

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

  26 weeks

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

  26 weeks

• Slope of regression line of Hb concentration per week

  26 weeks

• Variation of QOL

  26 weeks

Study Arms (2)

2

ACTIVE COMPARATOR

Drug: Epoetin beta

1

EXPERIMENTAL

Drug: R744

Interventions

R744 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.

1

Epoetin beta 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.

2

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 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

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 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

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

Related Publications (1)

• 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.

  PMID: 36791280 DERIVED

MeSH Terms

Interventions

epoetin beta

Study Officials

• Takanori Baba

  Chugai Pharmaceutical,Clinical Research Department 2

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 8, 2009

Record last verified: 2009-01

Locations

JP (6)