Clinical Study of R744 to Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00491868
First received: June 25, 2007
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Hemodialysis Patients
Drug: R744
Drug: rHuEPO
Drug: R744 placebo
Drug: rHuEPO placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta).

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Variation of Hb concentration from baseline Hb concentration in evaluation period [ Time Frame: week 17~24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: week 17~24 ] [ Designated as safety issue: No ]
  • Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb [ Time Frame: week 17~24 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Laboratory measurements [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Vital signs, standard 12-lead ECG [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Anti-R744 antibody titer [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Anti-Epoetin beta antibody titer [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 134
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: R744
100μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
Other Name: methoxy polyethylene glycol-epoetin beta
Drug: rHuEPO placebo
0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks
Experimental: 2 Drug: R744
150μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
Other Name: methoxy polyethylene glycol-epoetin beta
Drug: rHuEPO placebo
0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks
Active Comparator: 3 Drug: rHuEPO
2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
Drug: R744 placebo
0 μg/4week for 24 weeks
Active Comparator: 4 Drug: rHuEPO
4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
Drug: R744 placebo
0 μg/4week for 24 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 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

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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491868

Locations
Japan
Chubu region
Chubu, Japan
Chugoku/Shikoku region
Chugoku/Shikoku, 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 Chugai Pharmaceutical,Clinical Research Department 2
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00491868     History of Changes
Other Study ID Numbers: JH20876
Study First Received: June 25, 2007
Last Updated: January 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014