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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00228436
First received: September 27, 2005
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


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 Multiple Doses of Subcutaneously Administered Peginesatide in Chronic Kidney Disease Patients Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment

Resource links provided by NLM:


Further study details as provided by Affymax:

Primary Outcome Measures:
  • Percentage of participants who achieved a target hemoglobin response during the study. [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of adverse events and serious adverse events [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with hemoglobin values in the range of 11.0 to 13.0 g/dL throughout the study. [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: September 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Peginesatide starting dose of 0.05 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 2
Peginesatide starting dose of 0.075 mg/kg administered SC Q4W for a total of 6 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 3
Peginesatide starting dose of 0.025 mg/kg administered SC Q4W for a total of 6 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 4
Peginesatide starting dose of 0.05 mg/kg administered intravenously (IV) Q4W for a total of 6 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 5
Peginesatide starting dose of 0.025 mg/kg administered SC once every 2 weeks (Q2W) for a total of 12 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 6
Peginesatide starting dose of 0.0375 mg/kg administered SC Q2W for a total of 12 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 7
Peginesatide fixed starting dose of 4 mg administered SC Q4W for a total of 6 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Cohort 8
Peginesatide fixed starting dose of 3 mg administered SC Q4W for a total of 6 doses.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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 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;
  • 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.

Exclusion Criteria:

  • 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;
  • 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.
  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: NCT00228436

Locations
Poland
Research Facility
Białystok, Poland
Research Facility
Gdansk, Poland
Research Facility
Katowice, Poland
Research Facilities
Kraków, Poland
Research Facility
Warszawa, Poland
Research Facility
Łódź, Poland
United Kingdom
Research Facility
Coventry, United Kingdom
Research Facility
Croydon, United Kingdom
Research Facility
Derby, United Kingdom
Research Facility
Leicester, United Kingdom
Research Facilities
London, United Kingdom
Research Facility
Salford, United Kingdom
Research Facility
Swansea, United Kingdom
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: NCT00228436     History of Changes
Other Study ID Numbers: AFX01-04, 2005-002218-39
Study First Received: September 27, 2005
Last Updated: December 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Poland: The Central Register of Clinical Trials

Keywords provided by Affymax:
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

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014