NCT00228449

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

1.8 years

First QC Date

September 27, 2005

Last Update Submit

December 19, 2012

Conditions

AnemiaChronic Kidney DiseaseChronic Renal Failure

Keywords

anemiachronic kidney diseaseCKDchronic renal failureCRFdialysiserythropoietinEPOerythropoiesis stimulating agentESAHematide™hemodialysishemoglobinHbHgbOmontyspeginesatidered blood cellred blood cell production

Outcome Measures

Primary Outcomes (1)

  • Average weekly hemoglobin and hemoglobin change from baseline

    Baseline to Week 27

Secondary Outcomes (3)

  • Percentage of participants with hemoglobin within 1.0 gram per deciliter (g/dL) above or below baseline

    Baseline to Week 25

  • Percentage of participants who maintain hemoglobin within 9.5-13.0 g/dL

    Baseline to Week 25

  • Percentage of participants who maintain hemoglobin within 11.0-13.0 g/dL

    Baseline to Week 25

Study Arms (8)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

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

Cohorts 4 and 9

EXPERIMENTAL

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

Cohort 5

EXPERIMENTAL

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

Cohort 6

EXPERIMENTAL

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

Cohorts 7 and 8

EXPERIMENTAL

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

Cohorts 10 and 11

EXPERIMENTAL

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

Interventions

peginesatideDRUG
Also known as: Omontys, Hematide, AF37702 Injection
Cohort 1Cohort 2Cohort 3Cohort 5Cohort 6Cohorts 10 and 11Cohorts 4 and 9Cohorts 7 and 8

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Facility

Birmingham, Alabama, 35213, United States

Location

Research Facility

Pine Bluff, Arkansas, 71603, United States

Location

Research Facility

Los Angeles, California, 90095, United States

Location

Research Facility

Mountain View, California, 94041, United States

Location

Research Facility

Lauderdale Lakes, Florida, 33313, United States

Location

Research Facility

Pembroke Pines, Florida, 33028, United States

Location

Research Facility

Shreveport, Louisiana, 71101, United States

Location

Research Facility

Detroit, Michigan, 48202, United States

Location

Research Facility

Minneapolis, Minnesota, 55404, United States

Location

Research Facility

New York, New York, 10128, United States

Location

Research Facility

Canton, Ohio, 44718, United States

Location

Research Facility

Nashville, Tennessee, 37205, United States

Location

Research Facility

San Antonio, Texas, 78215, United States

Location

Research Facility

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • Besarab A, Zeig SN, Martin ER, Pergola PE, Whittier FC, Zabaneh RI, Schiller B, Mayo M, Francisco CA, Polu KR, Duliege AM. An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients. BMC Nephrol. 2012 Aug 30;13:95. doi: 10.1186/1471-2369-13-95.

    PMID: 22935486DERIVED

MeSH Terms

Conditions

AnemiaRenal Insufficiency, ChronicKidney Failure, Chronic

Interventions

peginesatidehematide

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Affymax

    Affymax, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

July 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

US(14)