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

September 27, 2005
December 19, 2012
September 2005
November 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00228436 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anemia
  • Chronic Kidney Disease
  • Chronic Renal Failure
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
  • 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.
    Intervention: Drug: peginesatide
  • Experimental: Cohort 2
    Peginesatide starting dose of 0.075 mg/kg administered SC Q4W for a total of 6 doses.
    Intervention: Drug: peginesatide
  • Experimental: Cohort 3
    Peginesatide starting dose of 0.025 mg/kg administered SC Q4W for a total of 6 doses.
    Intervention: Drug: peginesatide
  • Experimental: Cohort 4
    Peginesatide starting dose of 0.05 mg/kg administered intravenously (IV) Q4W for a total of 6 doses.
    Intervention: Drug: peginesatide
  • Experimental: Cohort 5
    Peginesatide starting dose of 0.025 mg/kg administered SC once every 2 weeks (Q2W) for a total of 12 doses.
    Intervention: Drug: peginesatide
  • Experimental: Cohort 6
    Peginesatide starting dose of 0.0375 mg/kg administered SC Q2W for a total of 12 doses.
    Intervention: Drug: peginesatide
  • Experimental: Cohort 7
    Peginesatide fixed starting dose of 4 mg administered SC Q4W for a total of 6 doses.
    Intervention: Drug: peginesatide
  • Experimental: Cohort 8
    Peginesatide fixed starting dose of 3 mg administered SC Q4W for a total of 6 doses.
    Intervention: Drug: peginesatide
Macdougall IC, Wiecek A, Tucker B, Yaqoob M, Mikhail A, Nowicki M, MacPhee I, Mysliwiec M, Smolenski O, Sułowicz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland,   United Kingdom
 
NCT00228436
AFX01-04, 2005-002218-39
No
Affymax
Affymax
Not Provided
Study Director: Affymax Affymax, Inc
Affymax
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP