Clinical Study of R744 to Peritoneal Dialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00433849
First received: February 8, 2007
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Peritoneal Dialysis Patients
Drug: R744
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Peritoneal Dialysis Patients (Phase Ⅲ Study)

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Slope of regression line of Hb concentration (g/dL/week) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Laboratory measurements [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Event [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Anti-R744 antibody titer [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs, standard 12-lead ECG [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: February 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: R744
100μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks
Experimental: 2 Drug: R744
150μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433849

Locations
Japan
Chubu region
Chubu, Japan
Chugoku/Shikoku region
Chugoku/Shikoku, Japan
Hokkaido/Tohoku region
Hokkaido/Tohoku, Japan
Kanto/Koshinetsu region
Kanto/Koshinetsu, Japan
Kinki/Hokuriku region
Kinki/Hokuriku, Japan
Kyusyu region
Kyusyu, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Chair: Takanori Baba Clinical Research Department 2
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00433849     History of Changes
Other Study ID Numbers: JH20564
Study First Received: February 8, 2007
Last Updated: January 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on April 16, 2014