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

NCT00109291 | Terminated Phase 2

• 2 other identifiers: AFX01-022005-000125-35
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

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)

• Incidence of adverse events and serious adverse events

  28 days

Secondary Outcomes (2)

• Pharmacokinetic parameters

  28 days

• Pharmacodynamic parameters

  28 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Single injection of placebo administered intravenously

Drug: Placebo

Peginesatide 0.025 mg/kg

EXPERIMENTAL

Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.

Drug: peginesatide

Peginesatide 0.05 mg/kg

EXPERIMENTAL

Single peginesatide dose of 0.05 mg/kg administered intravenously.

Drug: peginesatide

Peginesatide 0.10 mg/kg

EXPERIMENTAL

Single peginesatide dose of 0.10 mg/kg administered intravenously.

Drug: peginesatide

Interventions

Placebo DRUG

Placebo

peginesatide DRUG

Also known as: Omontys, Hematide, AF37702 Injection

Peginesatide 0.025 mg/kg; Peginesatide 0.05 mg/kg; Peginesatide 0.10 mg/kg

Eligibility Criteria

• Age: 18 Years - 75 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 ≤ 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;
• 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;
• 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;
• One serum ferritin level ≥ 100 micrograms per liter (µg/L) and one transferrin saturation ≥ 20% within 28 days prior to administration of study drug;
• One serum folate level above the lower limit of normal within 28 days prior to administration of study drug;
• One vitamin B12 level above the lower limit of normal within 28 days prior to administration of study drug;
• Weight ≥ 45 kg within 28 days prior to administration of study drug;
• One white blood cell count ≥ 3.0 x 10\^9/L within 28 days prior to administration of study drug; and
• One platelet count ≥ 140 x 10\^9/L and ≤ 500 x 10\^9/L within 28 days prior to administration of study drug.

You may not qualify if:

• Prior treatment with any erythropoiesis stimulating agent;
• History of pure red cell aplasia;
• Red blood cell transfusion within 3 months prior to study drug administration;
• Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.);
• Hemolysis based on medical judgment;
• Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
• C Reactive Protein (CRP) greater than 30 mg/L within 14 days prior to administration of study drug;
• Significant infection within 4 weeks prior to study drug administration, per Investigator's clinical judgment ;
• Febrile illness within 7 days prior to administration of study drug;
• 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 (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);
• Malignancy (except non-melanoma skin cancer);

Sponsors & Collaborators

• Affymax: lead

Study Sites (1)

Research Facility

London, United Kingdom

Location

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2005
• First Posted: April 27, 2005
• Study Start: March 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

GB (1)