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AnemiaPhase 2NCT00228449

Peginesatide for Anemia in Chronic Hemodialysis Patients

A Phase 2 study testing peginesatide in people with Anemia and Chronic Kidney Disease, run by Affymax at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
peginesatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
14 sitesUnited States
Study dates
Jul 2005to May 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Research Facility

    Birmingham, Alabama, 35213

  • Research Facility

    Canton, Ohio, 44718

  • Research Facility

    Detroit, Michigan, 48202

  • Research Facility

    Lauderdale Lakes, Florida, 33313

  • Research Facility

    Los Angeles, California, 90095

  • Research Facility

    Minneapolis, Minnesota, 55404

  • Research Facility

    Mountain View, California, 94041

  • Research Facility

    Nashville, Tennessee, 37205

  • Research Facility

    New York, New York, 10128

  • Research Facility

    Norfolk, Virginia, 23507

  • Research Facility

    Pembroke Pines, Florida, 33028

  • Research Facility

    Pine Bluff, Arkansas, 71603

  • Research Facility

    San Antonio, Texas, 78215

  • Research Facility

    Shreveport, Louisiana, 71101

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
peginesatide
Keywords
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
Medical subject headings
Anemia, Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peginesatideDrug

    Also called Omontys, Hematide, AF37702 Injection

Study groups in NCT00228449
Study groupRoleWhat they receive
Cohort 1ExperimentalConversion 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.
Receives: Drug: peginesatide
Cohort 2ExperimentalConversion 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.
Receives: Drug: peginesatide
Cohort 3ExperimentalConversion 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.
Receives: Drug: peginesatide
Cohorts 4 and 9ExperimentalConversion 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.
Receives: Drug: peginesatide
Cohort 5ExperimentalConversion 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.
Receives: Drug: peginesatide
Cohort 6ExperimentalConversion 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.
Receives: Drug: peginesatide
Cohorts 7 and 8ExperimentalConversion 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.
Receives: Drug: peginesatide
Cohorts 10 and 11ExperimentalConversion 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.
Receives: Drug: peginesatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average weekly hemoglobin and hemoglobin change from baseline

    Measured: Baseline to Week 27

Secondary outcomes (3)

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

    Measured: Baseline to Week 25

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

    Measured: Baseline to Week 25

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

    Measured: Baseline to Week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionMay 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00228449
Sponsor's protocol ID
AFX01-03
Status last verified
Dec 2012
First submitted
27 Sep 2005
Last updated
21 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22935486

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing peginesatide in people with Anemia and Chronic Kidney Disease, run by Affymax at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average weekly hemoglobin and hemoglobin change from baseline (time frame: Baseline to Week 27). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00228449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.

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