Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease

This study has been terminated.
(Due to slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00109291
First received: April 27, 2005
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis.


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Chronic Renal Failure
Drug: Placebo
Drug: peginesatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Patients With Chronic Kidney Disease Who Are Not on Dialysis and Who Have Not Had Prior Erythropoiesis Stimulating Agent (ESA) Treatment

Resource links provided by NLM:


Further study details as provided by Affymax:

Primary Outcome Measures:
  • Incidence of adverse events and serious adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters including Cmax, AUC0-t, AUC0-∞, t½ß, Vd, Vss, and Cl

  • Pharmacodynamic parameters [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Pharmacodynamic parameters including reticulocytes, hemoglobin, reticulocyte hemoglobin content, and serum measures of iron stores (e.g., serum ferritin, transferrin saturation, and transferrin receptor protein)


Enrollment: 17
Study Start Date: March 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Single injection of placebo administered intravenously
Drug: Placebo
Experimental: Peginesatide 0.025 mg/kg
Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Peginesatide 0.05 mg/kg
Single peginesatide dose of 0.05 mg/kg administered intravenously.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection
Experimental: Peginesatide 0.10 mg/kg
Single peginesatide dose of 0.10 mg/kg administered intravenously.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection

Detailed Description:

This was a Phase 2a, randomized, double-blind, placebo-controlled, sequential dose escalation study conducted at a single clinical center. The study was designed to evaluate up to 6 treatment cohorts of 9 participants with CKD not on dialysis in the first cohort and 5 participants in each subsequent cohort. In each treatment cohort, participants were randomly assigned to receive either a single dose of peginesatide (n=7 in the first cohort, n=4 in subsequent cohorts) or placebo (n=2 in the first cohort, n=1 in subsequent cohorts). Participants were followed for a minimum of 28 days.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. Males or females ≥ 18 and ≤ 75 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 2 weeks prior to study start, and must be willing to continue contraception for at least 4 weeks after receiving study drug;
  3. Chronic kidney disease stage 3 or 4 (glomerular filtration rate [GFR] of 15-60 milliliter per minute (mL/min) within 28 days prior to administration of study drug,) not requiring dialysis;
  4. Two hemoglobin values of ≥ 9 grams per deciliter (g/dL) and ≤ 11 g/dL within 14 days prior to administration of study drug, with one of the values drawn within 7 days prior to administration of study drug;
  5. One serum ferritin level ≥ 100 micrograms per liter (µg/L) and one transferrin saturation ≥ 20% within 28 days prior to administration of study drug;
  6. One serum folate level above the lower limit of normal within 28 days prior to administration of study drug;
  7. One vitamin B12 level above the lower limit of normal within 28 days prior to administration of study drug;
  8. Weight ≥ 45 kg within 28 days prior to administration of study drug;
  9. One white blood cell count ≥ 3.0 x 10^9/L within 28 days prior to administration of study drug; and
  10. One platelet count ≥ 140 x 10^9/L and ≤ 500 x 10^9/L within 28 days prior to administration of study drug.

Exclusion Criteria:

  1. Prior treatment with any erythropoiesis stimulating agent;
  2. History of pure red cell aplasia;
  3. Red blood cell transfusion within 3 months prior to study drug administration;
  4. Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.);
  5. Hemolysis based on medical judgment;
  6. Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
  7. C Reactive Protein (CRP) greater than 30 mg/L within 14 days prior to administration of study drug;
  8. Significant infection within 4 weeks prior to study drug administration, per Investigator's clinical judgment ;
  9. Febrile illness within 7 days prior to administration of study drug;
  10. Uncontrolled or symptomatic secondary hyperparathyroidism;
  11. 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);
  12. Epileptic seizure in the 6 months prior to study drug administration;
  13. Chronic congestive heart failure (New York Heart Association Class IV);
  14. 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 diseases or conditions within the past 6 months that may, in the Investigator's opinion, interfere with assessment or follow-up of the patient);
  15. Malignancy (except non-melanoma skin cancer);
  16. Life expectancy < 12 months;
  17. Anticipated elective surgery during the study period;
  18. Previous exposure to any investigational agent within 4 months 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: NCT00109291

Locations
United Kingdom
Research Facility
London, United Kingdom
Sponsors and Collaborators
Affymax
Investigators
Study Director: Affymax Affymax, Inc.
  More Information

No publications provided

Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00109291     History of Changes
Other Study ID Numbers: AFX01-02, 2005-000125-35
Study First Received: April 27, 2005
Last Updated: December 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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 August 19, 2014