Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

NCT01478971 | Completed Phase 3 Results

• 2 other identifiers: AFX01-18U1111-1150-2575
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.

Conditions

Chronic Kidney Disease; Anemia

Keywords

Anemia; Chronic Renal Failure; CRF; Chronic Kidney Disease; CKD; Erythropoietin; Hematide; Peginesatide; Hemoglobin; Hgb; Red Blood Cell; Red Blood Cell Production; Dialysis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Undergoing Conversion to Peginesatide Injection

  6 months

Secondary Outcomes (5)

• Peginesatide Dosing

  Month 6 - 12

• Peginesatide Dose Deviations

  Months 6 - 12

• Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL

  Months 1, 2, 3, 4, 5 and 6 of each treatment period

• Percentage of Participants Who Received at Least One Intravenous Iron Dose

  12 months

• Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion

  12 months

Study Arms (1)

peginesatide injection

EXPERIMENTAL

In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).

Drug: Epoetin; Drug: Peginesatide

Interventions

Epoetin DRUG

Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous \[IV\] or subcutaneous \[SC\]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of \<11 g/dL.

peginesatide injection

Peginesatide DRUG

Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at \<11 g/dL.

Also known as: Omontys

peginesatide injection

Eligibility Criteria

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

You may qualify if:

• Have provided written informed consent in accordance with institutional, local, and national guidelines
• Are ≥18 years of age at the start of screening
• Have been on in-center hemodialysis for ≥12 weeks at the start of screening
• Are currently maintained on Epoetin at the start of screening
• If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study
• If a female of childbearing potential, have a negative pregnancy test during screening

You may not qualify if:

• Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.)
• Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.)
• Have known intolerance to any ESA or PEGylated molecule
• Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study
• Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance
• Are pregnant or nursing

Sponsors & Collaborators

• Takeda: lead
• Affymax: collaborator

Study Sites (5)

Research Facility

Sacramento, California, 95825, United States

Location

Research Facility

San Diego, California, 91910, United States

Location

Research Facility

San Jose, California, 95128, United States

Location

Research Facility

North Brunswick, New Jersey, 08902, United States

Location

Research Facility

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia; Kidney Failure, Chronic

Interventions

Erythropoietin; peginesatide; hematide

Condition Hierarchy (Ancestors)

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; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 20, 2016
• Results First Posted: May 26, 2014

Record last verified: 2016-09

Locations

US (5)