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AnemiaPhase 2NCT00228436

Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients

A Phase 2 study testing peginesatide in people with Anemia and Chronic Kidney Disease, run by Affymax at 13 sites in 2 countries.

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 was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis stimulating agent (ESA) treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
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
139 participants
Where
13 sitesin 2 countries
Study dates
Sep 2005to Nov 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 to 80 years
  • 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 and ≤ 85 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 an adequate form of contraception for at least 4 weeks prior to study start, and must be willing to continue contraception for at least 4 weeks after the last dose of study drug;
  • Chronic kidney disease stage 3 or 4 (estimated Glomerular filtration rate [GFR] of 15-60 mL/min within 28 days prior to study drug administration) and not expected to begin dialysis for at least 12 weeks;
  • Two hemoglobin values of ≥ 9.0 and < 11.0 g/dL within 14 days prior to study drug administration, including at least one of the values drawn within 7 days prior to study drug administration;
  • One serum ferritin level ≥ 100 micrograms per liter (μg/L) and transferrin saturation ≥ 20 % within 4 weeks prior to study drug administration;
  • One serum or red cell folate level above lower limit of normal within 4 weeks prior to study drug administration;
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  • One vitamin B12 level above lower limit of normal within 4 weeks prior to study drug administration;
  • Weight ≥ 45 kg within 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 within 4 weeks prior to study drug administration.

Who cannot join

  • Prior treatment with any erythropoiesis stimulating agent in the 12 weeks prior to study drug administration;
  • Any prior treatment with Eprex®;
  • Known intolerance to any erythropoiesis stimulating agent;
  • History of antibodies to any erythropoiesis stimulating agent or history of pure red cell aplasia;
  • Prior hemodialysis or peritoneal dialysis treatment;
  • Known intolerance to parenteral iron supplementation;
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  • Red blood cell transfusion within 12 weeks prior to study drug administration;
  • Hemoglobinopathy [e.g., homozygous sickle-cell disease (sickle-cell trait does not exclude patient), thalassemia of all types, etc.];
  • Known hemolysis;
  • Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
  • C Reactive Protein (CRP) greater than 30 mg/L within the 4 weeks prior to study drug administration;
  • Febrile illness within 7 days prior to study drug administration;
  • Uncontrolled or symptomatic secondary hyperparathyroidism;
  • Poorly controlled hypertension within 4 weeks prior to study drug administration, per Investigator's clinical judgment (e.g. systolic ≥ 170mm Hg, diastolic ≥ 100 mm Hg on repeat readings);
  • Epileptic seizure in the 6 months prior to study drug administration;
  • Chronic congestive heart failure (New York Heart Association Class IV);
  • High likelihood of early withdrawal or interruption of the study;
  • 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

13 sites in 2 countries.

13 sites in 2 countries

United Kingdom7 sites

  • Research Facility

    Coventry

  • Research Facility

    Croydon

  • Research Facility

    Derby

  • Research Facility

    Leicester

  • Research Facilities

    London

  • Research Facility

    Salford

  • Research Facility

    Swansea

Other trials in United Kingdom

Poland6 sites

  • Research Facility

    Bialystok

  • Research Facility

    Gdansk

  • Research Facility

    Katowice

  • Research Facilities

    Krakow

  • Research Facility

    Lodz

  • Research Facility

    Warsaw

Other trials in Poland

About this study

Official title: A Phase 2, Open-label, Multi-center, Sequential Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Multiple Doses of Subcutaneously Administered Peginesatide in Chronic Kidney Disease Patients Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment

The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis stimulating agent (ESA) treatment.

Read the detailed description

This was a Phase 2, dose finding study designed to evaluate peginesatide treatment of participants with CKD not on ESA treatment. The objective was to determine the range of doses of peginesatide administered subcutaneously once every 4 weeks (Q4W) that increased and maintained hemoglobin at 11 to 13 g/dL.

Being tested
peginesatide
Keywords
anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide™, 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 NCT00228436
Study groupRoleWhat they receive
Cohort 1ExperimentalPeginesatide starting dose of 0.05 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses.
Receives: Drug: peginesatide
Cohort 2ExperimentalPeginesatide starting dose of 0.075 mg/kg administered SC Q4W for a total of 6 doses.
Receives: Drug: peginesatide
Cohort 3ExperimentalPeginesatide starting dose of 0.025 mg/kg administered SC Q4W for a total of 6 doses.
Receives: Drug: peginesatide
Cohort 4ExperimentalPeginesatide starting dose of 0.05 mg/kg administered intravenously (IV) Q4W for a total of 6 doses.
Receives: Drug: peginesatide
Cohort 5ExperimentalPeginesatide starting dose of 0.025 mg/kg administered SC once every 2 weeks (Q2W) for a total of 12 doses.
Receives: Drug: peginesatide
Cohort 6ExperimentalPeginesatide starting dose of 0.0375 mg/kg administered SC Q2W for a total of 12 doses.
Receives: Drug: peginesatide
Cohort 7ExperimentalPeginesatide fixed starting dose of 4 mg administered SC Q4W for a total of 6 doses.
Receives: Drug: peginesatide
Cohort 8ExperimentalPeginesatide fixed starting dose of 3 mg administered SC Q4W for a total of 6 doses.
Receives: Drug: peginesatide

What is being measured

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

  1. Percentage of participants who achieved a target hemoglobin response during the study.

    A target hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline and a hemoglobin value ≥ 11.0 g/dL during the study.

    Measured: 25 weeks

Secondary outcomes (3)

  1. Incidence of adverse events and serious adverse events

    Measured: 25 weeks

  2. Pharmacokinetic parameters

    Measured: 25 weeks

  3. Percentage of participants with hemoglobin values in the range of 11.0 to 13.0 g/dL throughout the study.

    Measured: 25 weeks

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 startSep 2005
  3. Primary completionNov 2007
  4. Study completionNov 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
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00228436
Sponsor's protocol ID
AFX01-04
Other IDs
2005-002218-39, 2005
Status last verified
Dec 2012
First submitted
27 Sep 2005
Last updated
21 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • Macdougall IC, Wiecek A, Tucker B, Yaqoob M, Mikhail A, Nowicki M, MacPhee I, Mysliwiec M, Smolenski O, Sulowicz W, Mayo M, Francisco C, Polu KR, Schatz PJ, Duliege AM. Dose-finding study of peginesatide for anemia correction in chronic kidney disease patients. Clin J Am Soc Nephrol. 2011 Nov;6(11):2579-86. doi: 10.2215/CJN.10831210. Epub 2011 Sep 22.

    PubMed 21940838

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 13 sites in 2 countries.

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 10 inclusion and 21 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 13 sites in United Kingdom, Poland. 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?

Percentage of participants who achieved a target hemoglobin response during the study. (time frame: 25 weeks). 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 NCT00228436, 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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