Clinical Study of R744 to Predialysis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00433615
• Date of registration: 09/02/2007
• Primary sponsor: Chugai Pharmaceutical
• Public title: Clinical Study of R744 to Predialysis Patients
• Scientific title: Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase ? Study ).
• Date of first enrolment: February 2007
• Target sample size: 124
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00433615
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Takanori Baba
• Affiliation: Clinical Research Department 2

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 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 <13.0 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 who are applicable to the following criteria ?), ?), ?), and whose mean
value of Hb concentrations determined within 8 weeks before registration has been >
12.0 g/dL

- ?)Patients with an anamnesis of myocardial infarction, pulmonary infarction or
cerebral infarction (excluding asymptomatic cerebral infarction)

- ?)Patients with complication of unstable angina pectoris or controlled angina
pectoris (hardly controlled regardless of drug treatment or interventional treatment
)

- ?)Patients with congestive cardiac failure (= Class II in Fontaine arteriosclerosis
obliterans classification)

- 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 sub-investigator



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia in Pre-Dialysis Patients

Intervention(s)

Drug: R744

Primary Outcome(s)

Ratio of Maintenance of target Hb concentration [Time Frame: 24th and 48th week]

Secondary Outcome(s)

Adverse events [Time Frame: 24th and 48th week]

Anti-R744 antibody titer [Time Frame: 24th and 48th week]

Laboratory measurements [Time Frame: 24th and 48th week]

Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL [Time Frame: 24th week]

Ratio of Maintenance of Hb concentration [Time Frame: 24th and 48th week]

Slope of regression line of Hb concentration (g/dL/week) [Time Frame: 24th week]

Vital signs, standard 12-lead ECG [Time Frame: 24th and 48th week]

Secondary ID(s)

JH20566

Source(s) of Monetary Support

Please refer to primary and secondary sponsors