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Study Complete
Sponsor ID
20050113

Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients with Chronic Kidney Disease Receiving Hemodialysis

Sponsor ID
20050113
Clinicaltrials.gov ID
NCT00146224
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to evaluate whether the efficacy of

Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment

of anemia in patients with CKD receiving hemodialysis

Additional Study Details

Phase
Phase 3
Product
epoetin alfa
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
420
Additional Study Details

Protocol Summary

Primary Outcome Measures

Ratio of weekly dose at the evaluation period to the weekly dose at baseline

Timeframe: Entire Study

Change in Heloglobin level between the screening period and the evaluation period

Timeframe: Entire Study

Secondary Outcome Measures

Change from baseline Hb at each measurement timepoint

Timeframe: Entire Study

Maintaining Hemoglobin within range at each measurement timepoint

Timeframe: Entire Study

Average Epoetin alfa dose over evaluation period

Timeframe: evaluation period (weeks 21 - 28)

Change from baseline dose at each measurement timepoint

Timeframe: entire study

Epoetin alfa seroreactivity

Timeframe: entire study

Subject incidence, nature and severity of adverse events

Timeframe: entire study

Hemoglobin variability

Timeframe: entire study

changes from baseline laboraotry and vital sign parameters

Timeframe: entire study

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Sep 2005 - Jan 2007
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization
    Exclusion Criteria:
    - Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy