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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00752791




Registration number
NCT00752791
Ethics application status
Date submitted
11/09/2008
Date registered
15/09/2008
Date last updated
15/08/2012

Titles & IDs
Public title
Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.
Scientific title
A Phase 2 Study of the Safety and Efficacy of Hematide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Subjects Previously Treated With Epoetin
Secondary ID [1] 0 0
2008-003458-13
Secondary ID [2] 0 0
AFX01_201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Peginesatide

Experimental: Peginesatide -


Treatment: Drugs: Peginesatide
Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Hemoglobin Between Baseline and the Evaluation Period - The primary efficacy endpoint was the mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to Enrollment and the hemoglobin on the day of Enrollment) and the Evaluation Period (mean hemoglobin from Weeks 20 to 25).
Timepoint [1] 0 0
Baseline and Week 20 to Week 25.
Secondary outcome [1] 0 0
Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period - Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Week 20 to Week 25). The target hemoglobin range was 10.0 to 12.0 g/dL.
The 95% confidence interval was calculated from the normal approximation with continuity correction.
Timepoint [1] 0 0
Week 20 to Week 25.
Secondary outcome [2] 0 0
Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL - Percentage of participants with a mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from measured at Weeks 20 to 25) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.
Timepoint [2] 0 0
Baseline and Week 20 to Week 25.
Secondary outcome [3] 0 0
Percentage of Participants With Red Blood Cell Transfusions - The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 1 - 19) and Evaluation Period (Weeks 20 -25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. One patient had the last study visit during the titration period and the transfusion after the titration period. This patient is excluded from the summary of evaluation period.
Timepoint [3] 0 0
Up to 25 weeks.
Secondary outcome [4] 0 0
Mean Hemoglobin During 4-week Intervals - Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). One patient did not have central lab hemoglobin value during a regularly scheduled visit during weeks 2-5.
Timepoint [4] 0 0
Up to 25 weeks.
Secondary outcome [5] 0 0
Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals - Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.
Timepoint [5] 0 0
Up to 25 weeks.
Secondary outcome [6] 0 0
Percentage of Participants With Dose Adjustments During the Study - The peginesatide dose was adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 1-19) and Evaluation Period (Weeks 20-25). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.
Timepoint [6] 0 0
From Week 4 to Week 25

Eligibility
Key inclusion criteria
1. The patient was a man or woman and 18 to 90 years of age, inclusive.

2. The patient had CKD and had been on peritoneal dialysis for =3 months before
enrollment.

3. The patient was on stable SC epoetin (alfa or beta) maintenance therapy continuously
prescribed for a minimum of 8 weeks prior to enrollment.

4. The patient had 4 consecutive Hb values with a mean =10.0 and =12.0 g/dL during the
screening period, with the difference between the mean of the first confirmed (2
consecutive) Hb values and the mean of the last confirmed (2 consecutive) Hb values
being =1.0 g/dL.

5. The patient had 1 ferritin level =100 ng/mL within 4 weeks before enrollment.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient had known bleeding or coagulation disorder.

2. The patient had known hematologic disease or cause of anemia other than renal disease
(e.g., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiple
myeloma, hemolytic anemia, and myelodysplastic syndrome).

3. The patient had received a recent course of intensive iron replacement (i.e., more
than 500 mg IV in the 28 days before enrollment).

4. The patient had advanced chronic congestive heart failure defined by New York Heart
Association Class III or IV.

5. The patient had a known history of seizure disorder or received antiepileptic
medication for a seizure disorder within 6 months before enrollment.

6. The patient had a scheduled kidney transplant. (Note: patients who were currently on a
transplant waiting list were not excluded unless there was an identified donor).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- New Lambtom
Recruitment postcode(s) [1] 0 0
- New Lambtom
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Italy
State/province [12] 0 0
Modena
Country [13] 0 0
New Zealand
State/province [13] 0 0
Dunedin
Country [14] 0 0
United Kingdom
State/province [14] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Affymax
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the efficacy and safety of peginesatide injection
for maintenance treatment of anemia in participants on peritoneal dialysis.
Trial website
https://clinicaltrials.gov/show/NCT00752791
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications