Clinical Study of R744 to Peritoneal Dialysis Patients

Sponsor

Chugai Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00433849

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Dialysis Patients	Drug: R744 Drug: R744	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL [48 weeks]

Secondary Outcome Measures

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]
Anti-R744 antibody titer [48 weeks]
Vital signs, standard 12-lead ECG [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Chubu region	Chubu	Japan
2	Chugoku/Shikoku region	Chugoku/Shikoku	Japan
3	Hokkaido/Tohoku region	Hokkaido/Tohoku	Japan
4	Kanto/Koshinetsu region	Kanto/Koshinetsu	Japan
5	Kinki/Hokuriku region	Kinki/Hokuriku	Japan
6	Kyusyu region	Kyusyu	Japan

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Chair: Takanori Baba, Clinical Research Department 2

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00433849

Other Study ID Numbers:

JH20564

First Posted:

Feb 12, 2007

Last Update Posted:

Feb 2, 2009

Last Verified:

Jan 1, 2009

Study Results

No Results Posted as of Feb 2, 2009