Clinical Study of R744 to Peritoneal Dialysis Patients

NCT00433849 | Completed Phase 3

• 1 other identifier: JH20564
• Study Type: interventional
• Target: 72
• 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 Peritoneal Dialysis.

Conditions

Peritoneal Dialysis Patients

Outcome Measures

Primary Outcomes (1)

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

  48 weeks

Secondary Outcomes (7)

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

  48 weeks

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

  48 weeks

• Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL

  48 weeks

• Laboratory measurements

  48 weeks

• Adverse Event

  48 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: R744

2

EXPERIMENTAL

Drug: R744

Interventions

R744 DRUG

100μg(i.v./p.o.)/4weeks for 8 weeks, then 25\~400μg(i.v./p.o.)/4weeks for 40 weeks

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 peritoneal dialysis 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 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 \<12.0 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 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 had an onset of peritonitis within 4 weeks before registration
• 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 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

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 8, 2007
• First Posted: February 12, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

JP (6)