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

NCT00228436 | Completed Phase 2

• 2 other identifiers: AFX01-042005-002218-39
• Study Type: interventional
• Target: 139
• Locations: 2 countries
• Sites: 13

Brief 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.

Conditions

Anemia; Chronic Kidney Disease; Chronic Renal Failure

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

Outcome Measures

Primary Outcomes (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.

  25 weeks

Secondary Outcomes (3)

• Incidence of adverse events and serious adverse events

  25 weeks

• Pharmacokinetic parameters

  25 weeks

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

  25 weeks

Study Arms (8)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

Peginesatide starting dose of 0.075 mg/kg administered SC Q4W for a total of 6 doses.

Drug: peginesatide

Cohort 3

EXPERIMENTAL

Peginesatide starting dose of 0.025 mg/kg administered SC Q4W for a total of 6 doses.

Drug: peginesatide

Cohort 4

EXPERIMENTAL

Peginesatide starting dose of 0.05 mg/kg administered intravenously (IV) Q4W for a total of 6 doses.

Drug: peginesatide

Cohort 5

EXPERIMENTAL

Peginesatide starting dose of 0.025 mg/kg administered SC once every 2 weeks (Q2W) for a total of 12 doses.

Drug: peginesatide

Cohort 6

EXPERIMENTAL

Peginesatide starting dose of 0.0375 mg/kg administered SC Q2W for a total of 12 doses.

Drug: peginesatide

Cohort 7

EXPERIMENTAL

Peginesatide fixed starting dose of 4 mg administered SC Q4W for a total of 6 doses.

Drug: peginesatide

Cohort 8

EXPERIMENTAL

Peginesatide fixed starting dose of 3 mg administered SC Q4W for a total of 6 doses.

Drug: peginesatide

Interventions

peginesatide DRUG

Also known as: Omontys, Hematide, AF37702 Injection

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Affymax: lead

Study Sites (13)

Research Facility

Bialystok, Poland

Location

Research Facility

Gdansk, Poland

Location

Research Facility

Katowice, Poland

Location

Research Facilities

Krakow, Poland

Location

Research Facility

Lodz, Poland

Location

Research Facility

Warsaw, Poland

Location

Research Facility

Coventry, United Kingdom

Location

Research Facility

Croydon, United Kingdom

Location

Research Facility

Derby, United Kingdom

Location

Research Facility

Leicester, United Kingdom

Location

Research Facilities

London, United Kingdom

Location

Research Facility

Salford, United Kingdom

Location

Research Facility

Swansea, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21940838 DERIVED

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Affymax

  Affymax, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: September 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

PL (6); GB (7)