Clinical Study of R744 to Hemodialysis Patients

NCT00491868 | Completed Phase 3 DMC

• 1 other identifier: JH20876
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Hemodialysis Patients

Outcome Measures

Primary Outcomes (1)

• Variation of Hb concentration from baseline Hb concentration in evaluation period

  week 17~24

Secondary Outcomes (7)

• Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL and maintain Hb concentration in the range of ≥ 9.0g/dL and ≤ 12.0g/dL in evaluation period

  week 17~24

• Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb

  week 17~24

• Adverse events

  throughout study

• Laboratory measurements

  throughout study

• Vital signs, standard 12-lead ECG

  throughout study

Study Arms (4)

1

EXPERIMENTAL

Drug: R744; Drug: rHuEPO placebo

2

EXPERIMENTAL

Drug: R744; Drug: rHuEPO placebo

3

ACTIVE COMPARATOR

Drug: rHuEPO; Drug: R744 placebo

4

ACTIVE COMPARATOR

Drug: rHuEPO; Drug: R744 placebo

Interventions

R744 DRUG

100μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks

Also known as: methoxy polyethylene glycol-epoetin beta

1

rHuEPO DRUG

2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks

3

R744 placebo DRUG

0 μg/4week for 24 weeks

3; 4

rHuEPO placebo DRUG

0 IU 2 or 3 times/week for 8 weeks, then 1\~3 times/week for 16 weeks

1; 2

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 3 times a week for at least 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 week for at least 8 weeks before registration
• Within 4 weeks before registration, patients who have been receiving a rHuEPO preparation 750IU (3 times a week), 1,500IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), 1,500IU (3 times a week), or 3,000IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), and patients who have not change dosage and administration.
• Patients whose pre-dialysis Hb concentrations has been between ≥ 9.0 g/dL and ≤12.0 g/dL and mean value of pre-dialysis Hb concentrations has been between ≥ 9.5 g/dL and ≤11.5 g/dL determined at the beginning of each week within 8 weeks before registration
• 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, testosterone propionate, methyltestosterone 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 (5)

Chugoku/Shikoku region

Chugoku/Shikoku, Japan

Location

Chubu region

Chūbu, 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

  Chugai Pharmaceutical,Clinical Research Department 2

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

JP (5)