Clinical trial NCT00752791: Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.
Official title: A Phase 2 Study of the Safety and Efficacy of Hematide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Subjects Previously Treated With Epoetin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Keywords: Anemia
Drug Therapy
Peritoneal Dialysis.
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Affymax
First posted: 2008-09-15
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of peginesatide injection for maintenance treatment of anemia in participants on peritoneal dialysis.

Detailed description: According to the International Federation of Renal Registries, in 1999 the prevalence of peritoneal dialysis in the United States as approximately 9.5% of patients receiving dialysis (2005 United States Renal Data Systems data indicates a prevalence of around 7.5%). Data from Europe in 1999 to 2000 (not including the United Kingdom, France or Germany) indicated peritoneal dialysis was the mode of dialysis in approximately 11.1% of dialysis patients. 2006 data from the United Kingdom indicates that more than 20% of patients on dialysis are receiving peritoneal dialysis while French and German data indicate rates of 8.1% and 4.8% respectively. More than 90% of patients with chronic renal failure/chronic kidney disease Stage 5 (End Stage Renal Disease) are anemic. The vast majority of patients receiving hemodialysis or peritoneal dialysis receive erythropoiesis-stimulating agent therapy to treat their anemia.

Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with chronic kidney disease (CKD) Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life.

Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure participants, and have improved the management of anemia over alternatives such as transfusion. Peginesatide (hematide) is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Participants in this study received variable doses of peginesatide injection once every four weeks. Total commitment time for this study was about 29 weeks.

Eligibility criteria: Inclusion Criteria:

1. The patient was a man or woman and 18 to 90 years of age, inclusive.
2. The patient had CKD and had been on peritoneal dialysis for ≥3 months before enrollment.
3. The patient was on stable SC epoetin (alfa or beta) maintenance therapy continuously prescribed for a minimum of 8 weeks prior to enrollment.
4. The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during the screening period, with the difference between the mean of the first confirmed (2 consecutive) Hb values and the mean of the last confirmed (2 consecutive) Hb values being ≤1.0 g/dL.
5. The patient had 1 ferritin level ≥100 ng/mL within 4 weeks before enrollment.

Exclusion Criteria:

1. The patient had known bleeding or coagulation disorder.
2. The patient had known hematologic disease or cause of anemia other than renal disease (e.g., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome).
3. The patient had received a recent course of intensive iron replacement (i.e., more than 500 mg IV in the 28 days before enrollment).
4. The patient had advanced chronic congestive heart failure defined by New York Heart Association Class III or IV.
5. The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months before enrollment.
6. The patient had a scheduled kidney transplant. (Note: patients who were currently on a transplant waiting list were not excluded unless there was an identified donor).

Primary outcomes:
measure: Mean Change in Hemoglobin Between Baseline and the Evaluation Period
timeFrame: Baseline and Week 20 to Week 25.
Secondary outcomes:
measure: Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period
timeFrame: Week 20 to Week 25.
measure: Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL
timeFrame: Baseline and Week 20 to Week 25.
measure: Percentage of Participants With Red Blood Cell Transfusions
timeFrame: Up to 25 weeks.
measure: Mean Hemoglobin During 4-week Intervals
timeFrame: Up to 25 weeks.
measure: Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals
timeFrame: Up to 25 weeks.
measure: Percentage of Participants With Dose Adjustments During the Study
timeFrame: From Week 4 to Week 25
Other outcomes:
Locations:
city: Azusa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Whittier
country: United States
state: California
city: Naples
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Evergreen Park
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: New Iberia
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Columbus
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: New York
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Arlington
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Mechanicsville
country: United States
state: Virginia
city: New Lambtom
country: Australia
state: New South Wales
city: Modena
country: Italy
city: Dunedin
country: New Zealand
city: London
country: United Kingdom
state: England
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: