Peginesatide for Anemia in Chronic Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00228449
First received: September 27, 2005
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Chronic Renal Failure
Drug: peginesatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Multi-center, Sequential, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Peginesatide Administered Intravenously for the Maintenance Treatment of Anemia in Chronic Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Affymax:

Primary Outcome Measures:
  • Average weekly hemoglobin and hemoglobin change from baseline [ Time Frame: Baseline to Week 27 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with hemoglobin within 1.0 gram per deciliter (g/dL) above or below baseline [ Time Frame: Baseline to Week 25 ] [ Designated as safety issue: No ]
  • Percentage of participants who maintain hemoglobin within 9.5-13.0 g/dL [ Time Frame: Baseline to Week 25 ] [ Designated as safety issue: No ]
  • Percentage of participants who maintain hemoglobin within 11.0-13.0 g/dL [ Time Frame: Baseline to Week 25 ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: July 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Conversion from epoetin alfa to peginesatide with a conversion factor (CF) of 0.033: peginesatide dose administered intravenously once every 4 weeks (Q4W) for a total of up to 6 doses. No transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 2
Conversion from epoetin alfa to peginesatide with a CF of 0.041: peginesatide dose administered intravenously Q4W for a total of 6 doses. No transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 3
Conversion from epoetin alfa to peginesatide with a CF of 0.050: peginesatide dose administered intravenously Q4W for a total of 6 doses. No transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohorts 4 and 9
Conversion from epoetin alfa to peginesatide with a CF of 0.050: peginesatide dose administered intravenously Q4W for a total of 6 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 5
Conversion from epoetin alfa to peginesatide with a CF of 0.066: peginesatide dose administered intravenously Q4W for a total of 6 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 6
Conversion from epoetin alfa to peginesatide with tiered peginesatide starting doses of 0.05, 0.075, 0.1 or 0.15 mg/kg based on total weekly doses of epoetin alfa . Doses were administered intravenously Q4W for a total of 6 doses. With transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohorts 7 and 8
Conversion from epoetin alfa to peginesatide with tiered peginesatide starting doses of 0.05, 0.075, 0.1 or 0.15 mg/kg based on total weekly doses of epoetin alfa dose. Doses were administered intravenously Q4W for a total of 6 doses. No transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohorts 10 and 11
Conversion from epoetin alfa to peginesatide with fixed peginesatide starting doses of 4, 6, 12 or 16 mg based on total weekly doses of epoetin alfa. Doses were administered intravenously Q4W for a total of 6 doses. No transition period between epoetin treatment and start of peginesatide treatment.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection

Detailed Description:

This was a Phase 2, multicenter, open-label, sequential, dose-finding trial designed with up to 12 treatment cohorts of 15 participants per cohort. Each participant received an intravenous dose of peginesatide administered once every 4 weeks (Q4W) for a total of 6 doses. Dosage regimens varied by cohort. Participants were followed for a minimum of 42 days after the last administration of peginesatide.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines;
  • Males or females ≥ 18 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study start, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of the study) or vasectomized partner;
  • Clinically stable on hemodialysis for ≥6 months prior to study drug administration;
  • Urea clearance/volume (Kt/V) ≥ 1.2 within the 4 weeks prior to study drug administration;
  • Epoetin alfa maintenance therapy of ≥ 60 and ≤ 375 U/kg/wk continuously prescribed for 8 weeks prior to study drug administration. In the last 3 weeks prior to study drug administration, variation in prescribed total weekly dose must be ≤ 25% from the mean of the last three prescribed total weekly doses;
  • Three mid- or end-of-week hemoglobin values of ≥ 10.0 and ≤ 12.5 g/dL in the 3 weeks prior to study drug administration with ≤ 1.2 g/dL difference between the three values;
  • One serum ferritin level ≥ 100 micrograms per liter (μg/L) or one transferrin saturation ≥ 20% or one reticulocyte hemoglobin content (CHr) ≥ 29 picograms within 4 weeks prior to study drug administration;
  • One serum folate level above the lower limit of normal during the 4 weeks prior to study drug administration;
  • One vitamin B12 level above the lower limit of normal during the 4 weeks prior to study drug administration;
  • Weight ≥ 45 kilograms (kg) within the 4 weeks prior to study drug administration;
  • One white blood cell count ≥ 3.0 x 10^9/L within 4 weeks prior to study drug administration; and
  • One platelet count ≥ 100 x 10^9/L and ≤ 500 x 10^9/L within 4 weeks prior to study drug administration.

Exclusion Criteria:

  • Known intolerance to erythropoiesis stimulating agents;
  • History of antibodies to erythropoiesis stimulating agents or history of pure red cell aplasia;
  • Known intolerance to parenteral iron supplementation;
  • Red blood cell transfusion within 12 weeks prior to study drug administration;
  • Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.);
  • Known hemolysis;
  • Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
  • C-reactive protein greater than 30 mg/L within the 4 weeks prior to study drug administration;
  • Moderate or significant infection within 2 weeks prior to study drug administration;
  • Known coagulation disorder based on clinical context and laboratory [activated partial thromboplastin time (aPTT) or international normalized ratio (INR)] results;
  • Temporary (untunneled) dialysis access catheter;
  • Uncontrolled or symptomatic secondary hyperparathyroidism;
  • Poorly controlled hypertension within the 4 weeks prior to study drug administration, per the Investigator's clinical judgment (e.g., systolic ≥ 170 mm Hg or diastolic ≥ 100 mm Hg on repeat readings);
  • Any history of multiple significant drug allergies;
  • History of severe or unstable reactive airway disease within the previous 10 years;
  • Epileptic seizure in the 6 months prior to screening;
  • Chronic congestive heart failure (New York Heart Association Class IV);
  • High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical disease or conditions in the prior 6 months that may, in the Investigator's opinion, interfere with assessment or follow-up of the patient);
  • Evidence of malignancy within the past 5 years (except non-melanoma skin cancer which is not an exclusion criterion);
  • Life expectancy < 12 months;
  • Anticipated elective surgery during the study period; and
  • Previous exposure to any investigational agent within 6 weeks prior to administration of study drug or planned receipt during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228449

Locations
United States, Alabama
Research Facility
Birmingham, Alabama, United States, 35213
United States, Arkansas
Research Facility
Pine Bluff, Arkansas, United States, 71603
United States, California
Research Facility
Los Angeles, California, United States, 90095
Research Facility
Mountain View, California, United States, 94041
United States, Florida
Research Facility
Lauderdale Lakes, Florida, United States, 33313
Research Facility
Pembroke Pines, Florida, United States, 33028
United States, Louisiana
Research Facility
Shreveport, Louisiana, United States, 71101
United States, Michigan
Research Facility
Detroit, Michigan, United States, 48202
United States, Minnesota
Research Facility
Minneapolis, Minnesota, United States, 55404
United States, New York
Research Facility
New York, New York, United States, 10128
United States, Ohio
Research Facility
Canton, Ohio, United States, 44718
United States, Tennessee
Research Facility
Nashville, Tennessee, United States, 37205
United States, Texas
Research Facility
San Antonio, Texas, United States, 78215
United States, Virginia
Research Facility
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Affymax
Investigators
Study Director: Affymax Affymax, Inc.
  More Information

No publications provided by Affymax

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00228449     History of Changes
Other Study ID Numbers: AFX01-03
Study First Received: September 27, 2005
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Affymax:
anemia
chronic kidney disease
CKD
chronic renal failure
CRF
dialysis
erythropoietin
EPO
erythropoiesis stimulating agent
ESA
Hematide™
hemodialysis
hemoglobin
Hb
Hgb
Omontys
peginesatide
red blood cell
red blood cell production

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014