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CompletedNCT00440466Updated Apr 21, 2014Results posted

PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

A Phase 3 interventional study of epoetin alfa and epoetin alfa in Anemia and Renal Diseases, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 66 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-21.

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
430
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Read the detailed description

A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

02

Conditions studied

  • Anemia
  • Renal Diseases

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Keywords

  • Anemia
  • Reduction in the number of erythrocytes
  • Hemoglobin low level
  • Red blood cell deficiency
  • Procrit
  • Epoetin alfa
  • Chronic kidney disease
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 430 is above the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) >=15 mL/min per 1.73 m2 and \<60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
  • Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization
  • History of increase in hemoglobin after the initial dose
  • Stable dose of epoetin alfa given once-weekly before randomization.

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled hypertension
  • Iron deficiency
  • iron overload
  • severe congestive heart failure
  • Active infection
  • Recent heart attack, Stroke or blood clot.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
430 participants (actual)

Study arms

  • Experimental
    001

    epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks

    Drug: epoetin alfa

  • Experimental
    003

    epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

    Drug: epoetin alfa

  • Experimental
    002

    epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

    Drug: epoetin alfa

Interventions

  • Drugepoetin alfa

    Continue pre-study once weekly dose of epoetin alfa for 36 weeks

  • Drugepoetin alfa

    Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

  • Drugepoetin alfa

    Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

06

What researchers measure

Primary outcomes

  1. Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment

    Time frame: from baseline (Week 1) to the last 12 weeks of treatment

Secondary outcomes

  1. Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)

    Time frame: Weeks 13-37

Other outcomes

  1. Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)

    Time frame: 36 weeks of treatment

  2. Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)

    Time frame: 36 weeks of treatment

  3. Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

    Time frame: 36 weeks of treatment

  4. Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

    Time frame: 36 weeks of treatment

  5. Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

    Time frame: 36 weeks of treatment

  6. Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)

    Time frame: 36 weeks of treatment

  7. Number of Participants Who Died

    Time frame: 36 weeks of treatment

07

Results

Posted Apr 14, 2011

Participant flow

Participant flow — Overall Study
MilestoneEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Started108107215
Completed9592174
Not completed131541
Withdrew: Death329
Withdrew: Adverse event3411
Withdrew: Lost to follow-up102
Withdrew: Physician decision201
Withdrew: Protocol violation204
Withdrew: Withdrawal by subject259
Withdrew: Began dialysis001
Withdrew: Met hemoglobin withdrawal criteria044

Outcome measures

PrimaryChange in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment
Time frame:
from baseline (Week 1) to the last 12 weeks of treatment
Reported as:
Mean · g/dL
Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment
g/dLEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment-0.02 ± 0.728-0.10 ± 0.774-0.19 ± 0.738
Statistical analysis
  • Epoetin Alfa QW vs Epoetin Alfa Q2W · ANCOVA · Difference of least squares means: -0.03 · 95% CI -0.208 to 0.153
  • Epoetin Alfa QW vs Epoetin Alfa Q4W · ANCOVA · Difference of least squares means: -0.09 · 95% CI -0.249 to 0.063
SecondaryProportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)
Time frame:
Weeks 13-37
Reported as:
Median · Proportion
Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)
ProportionEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)0.87 (0.3 to 1.0)0.88 (0.0 to 1.0)0.83 (0.0 to 1.0)
Other pre-specifiedParticipants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)
Time frame:
36 weeks of treatment
Reported as:
Number · Participants
Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)
ParticipantsEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)7989161
Statistical analysis
  • Epoetin Alfa QW vs Epoetin Alfa Q2W · 95% Confidence Interval · Difference in percentage of participants: 10.9 · 95% CI 0.1 to 21.7
  • Epoetin Alfa QW vs Epoetin Alfa Q4W · 95% of Confidence Interval · Difference in percentage of participants: 1.1 · 95% CI -9.1 to 11.2
Other pre-specifiedMaximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)
Time frame:
36 weeks of treatment
Reported as:
Mean · g/dL
Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)
g/dLEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)12.35 ± 0.82812.48 ± 0.76012.46 ± 0.988
Statistical analysis
  • Epoetin Alfa QW vs Epoetin Alfa Q2W · ANOVA · Difference in least squares means: 0.13 · 95% CI -0.113 to 0.372
  • Epoetin Alfa QW vs Epoetin Alfa Q4W · ANOVA · Difference in least squares means: 0.11 · 95% CI -0.098 to 0.320
Other pre-specifiedParticipants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
Time frame:
36 weeks of treatment
Reported as:
Number · Particpants
Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
ParticpantsEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise8491191
Statistical analysis
  • Epoetin Alfa QW vs Epoetin Alfa Q2W · 95% of Confidence Interval · Difference in percentage of participants: 8.2 · 95% CI -2.0 to 18.3
  • Epoetin Alfa QW vs Epoetin Alfa Q4W · 95% of Confidence Interval · Difference in percentage of participants: 10.3 · 95% CI 1.5 to 19.2
Other pre-specifiedParticipants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
Time frame:
36 weeks of treatment
Reported as:
Number · Participants
Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
ParticipantsEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise5257124
Statistical analysis
  • Epoetin Alfa QW vs Epoetin Alfa Q2W · 95% of Confidence Interval · Difference in percentage of participants: 5.7 · 95% CI -7.7 to 19.1
  • Epoetin Alfa QW vs Epoetin Alfa Q4W · 95% of Confidence Interval · Difference in percentage of participants: 9.1 · 95% CI -2.5 to 20.6
Other pre-specifiedParticipants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
Time frame:
36 weeks of treatment
Reported as:
Number · Participants
Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
ParticipantsEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise373368
Statistical analysis
  • Epoetin Alfa QW vs Epoetin Alfa Q2W · 95% of Confidence Interval · Difference in percentage of participants: -3.2 · 95% CI -15.8 to 9.5
  • Epoetin Alfa QW vs Epoetin Alfa Q4W · 95% of Confidence Interval · Difference in percentage of participants: -3.0 · 95% CI -13.9 to 8.0
Other pre-specifiedMaximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)
Time frame:
36 weeks of treatment
Reported as:
Mean · g/dL/2 weeks
Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)
g/dL/2 weeksEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)1.77 ± 1.0681.69 ± 0.7901.81 ± 1.173
Statistical analysis
  • Epoetin Alfa QW vs Epoetin Alfa Q2W · ANOVA · Difference in least squares means: -0.08 · 95% CI -0.367 to 0.208
  • Epoetin Alfa QW vs Epoetin Alfa Q4W · ANOVA · Difference in least squares means: 0.04 · 95% CI -0.206 to 0.289
Other pre-specifiedNumber of Participants Who Died
Time frame:
36 weeks of treatment
Reported as:
Number · Participants
Number of Participants Who Died
ParticipantsEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Number of Participants Who Died439

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Epoetin Alfa QW—24/108 (22.2%)59/108 (54.6%)
Epoetin Alfa Q2W—28/107 (26.2%)59/107 (55.1%)
Epoetin Alfa Q4W—56/215 (26%)116/215 (54%)
Most frequent serious events
Showing 10 of 121
Most frequent serious events
EventEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
Cardiac failure congestiveCardiac disorders5/1088/1074/215
Renal failure acuteRenal and urinary disorders5/1085/1071/215
AnaemiaBlood and lymphatic system disorders2/1084/1071/215
Chest painGeneral disorders4/1082/1073/215
DehydrationMetabolism and nutrition disorders3/1082/1070/215
Acute myocardial infarctionCardiac disorders1/1082/1070/215
Renal failure chronicRenal and urinary disorders0/1082/1071/215
Pulmonary oedemaRespiratory, thoracic and mediastinal disorders1/1082/1071/215
Myocardial infarctionCardiac disorders2/1080/1072/215
Sudden cardiac deathGeneral disorders2/1080/1070/215
Most frequent other events
Showing 10 of 20
Most frequent other events
EventEpoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4W
HypertensionVascular disorders11/10814/10724/215
OedemaGeneral disorders5/10813/10716/215
Urinary tract infectionInfections and infestations12/1088/10713/215
Oedema peripheralGeneral disorders6/10810/10714/215
HyperkalaemiaMetabolism and nutrition disorders7/1087/10718/215
DizzinessNervous system disorders3/1087/10718/215
DiarrhoeaGastrointestinal disorders8/1085/10714/215
ConstipationGastrointestinal disorders5/1085/10715/215
FatigueGeneral disorders6/1085/10715/215
NasopharyngitisInfections and infestations4/1086/10715/215

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Epoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4WTotal
<=18 years0000
Between 18 and 65 years332657116
>=65 years7581158314
Age, Continuous
Age, Continuous(years)Epoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4WTotal
Mean70.3 ± 13.0471.7 ± 10.6371.1 ± 12.4871 ± 12.18
Sex: Female, Male
Sex: Female, Male(Participants)Epoetin Alfa QWEpoetin Alfa Q2WEpoetin Alfa Q4WTotal
Female6873126267
Male403489163
08

Study locations

66 sites
  • Chula Vista, California, United States
  • Fountain Valley, California, United States
  • Los Angeles, California, United States
  • Lynwood, California, United States
  • Orange, California, United States
  • Riverside, California, United States
  • San Dimas, California, United States
  • West Hills, California, United States
  • Yuba City, California, United States
  • Lakewood, Colorado, United States
  • Thornton, Colorado, United States
  • Washington, District of Columbia, United States
  • Clearwater, Florida, United States
  • Miami, Florida, United States
  • Pembroke Pines, Florida, United States
  • Plantation, Florida, United States
  • Springhill, Florida, United States
  • Tampa, Florida, United States
  • West Palm Beach, Florida, United States
  • Zephyrhills, Florida, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Macon, Georgia, United States
  • Chicago, Illinois, United States
  • Evergreen Park, Illinois, United States
  • Peoria, Illinois, United States
  • Shreveport, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Methuen, Massachusetts, United States
  • Plymouth, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Detroit, Michigan, United States
  • Flint, Michigan, United States
  • Picayune, Mississippi, United States
  • St. Louis, Missouri, United States
  • Great Neck, New York, United States
  • New York, New York, United States
  • Springfield Gardens, New York, United States
  • Charlotte, North Carolina, United States
  • Greenville, North Carolina, United States
  • Monroe, North Carolina, United States
  • Dayton, Ohio, United States
  • Maumee, Ohio, United States
  • Allentown, Pennsylvania, United States
  • Doylestown, Pennsylvania, United States
  • Erie, Pennsylvania, United States
  • Lancaster, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Wynnewood, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Bamberg, South Carolina, United States
  • Columbia, South Carolina, United States
  • Orangeburg, South Carolina, United States
  • Rock Hill, South Carolina, United States
  • Sumter, South Carolina, United States
  • Arlington, Texas, United States
  • Fountain Valley, Texas, United States
  • Houston, Texas, United States
  • Longview, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States
  • Hampton, Virginia, United States
  • Petersburg, Virginia, United States
  • Richmond, Virginia, United States
  • Tacoma, Washington, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00440466
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible party
Sponsor
First posted
Feb 27, 2007
Start date
Jul 2007
Primary completion
Mar 2009
Completion
Mar 2009
Results posted
Apr 14, 2011
Last update
Apr 21, 2014

Study contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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