Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

• Sponsor: Amgen (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01737879
• Collaborator: (none)
• Enrollment: 41
• Locations: 23
• Arm: 1
• Duration (Months): 9
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Drug: Peginesatide; Drug: Epoetin alfa	Phase 4

Detailed Description

This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peginesatide / Epoetin Alfa Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.	Drug: Peginesatide; All participants will receive peginesatide for the first 24 weeks.; Other Names: Omontys ; Drug: Epoetin alfa; All participants converted to epoetin alfa at week 25 for a total of 32 weeks; Other Names: Epogen

Outcome Measures

Primary Outcome Measures

1. Mean Hemoglobin Concentration During the Evaluation Period [Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).]

   The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants. No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.

Secondary Outcome Measures

1. Mean Dose of Epoetin Alfa During the Evaluation Period [Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).]

   No participant reached the evaluation period, therefore, this endpoint could not be evaluated.

2. Hemoglobin Concentration by Visit [Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21]

3. Peginesatide Dose by Visit [Baseline and Weeks 5, 9, 13, and 17]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Receiving hemodialysis 3 times a week

• Receiving epoetin alfa IV 3 times a week

• Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening

Key Exclusion Criteria:

• Systemic hematologic disease

• Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Phoenix	Arizona	United States	85004
2	Research Site	Tempe	Arizona	United States	85284
3	Research Site	Azusa	California	United States	91702
4	Research Site	Bakersfield	California	United States	93309
5	Research Site	Granada Hills	California	United States	91344
6	Research Site	Los Angeles	California	United States	90057
7	Research Site	Lynwood	California	United States	90262
8	Research Site	Paramount	California	United States	90723
9	Research Site	Riverside	California	United States	92501
10	Research Site	Whittier	California	United States	90603
11	Research Site	Orange	Connecticut	United States	06477
12	Research Site	Meridian	Idaho	United States	83642
13	Research Site	Kansas City	Missouri	United States	64111
14	Research Site	Bayonne	New Jersey	United States	07002
15	Research Site	Amherst	New York	United States	14221
16	Research Site	Yonkers	New York	United States	10704
17	Research Site	Winston-Salem	North Carolina	United States	27103
18	Research Site	Oklahoma City	Oklahoma	United States	73116
19	Research Site	Orangeburg	South Carolina	United States	29118
20	Research Site	Dyersburg	Tennessee	United States	38024
21	Research Site	Jackson	Tennessee	United States	38305
22	Research Site	Houston	Texas	United States	77004
23	Research Site	Chesapeake	Virginia	United States	23320

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01737879
• Other Study ID Numbers: 20110209
• First Posted: Nov 30, 2012
• Last Update Posted: Apr 21, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Amgen: Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin
• Additional relevant MeSH terms: Anemia; Epoetin Alfa

Study Results

Participant Flow

Recruitment Details	First patient was enrolled on 24 October 2012; Last patient was enrolled on 21 February 2013. The study was terminated on 27 March 2013.

Arm/Group Title	Peginesatide
Arm/Group Description	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Period Title: Overall Study
STARTED	41
Received Peginesatide	34
Transitioned to Epoetin Alfa	0
COMPLETED	0
NOT COMPLETED	41

Baseline Characteristics

Arm/Group Title	Peginesatide
Arm/Group Description	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Overall Participants	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.2 (16.6)
Sex: Female, Male (Count of Participants)
Female	21 51.2%
Male	20 48.8%
Race/Ethnicity, Customized (participants) [Number]
Black or African American	24 58.5%
White	16 39%
Other	1 2.4%

Outcome Measures

1. Primary Outcome

Title	Mean Hemoglobin Concentration During the Evaluation Period
Description	The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants. No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.
Time Frame	Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peginesatide
Arm/Group Description	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Measure Participants	0

2. Secondary Outcome

Title	Mean Dose of Epoetin Alfa During the Evaluation Period
Description	No participant reached the evaluation period, therefore, this endpoint could not be evaluated.
Time Frame	Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peginesatide
Arm/Group Description	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Measure Participants	0

3. Secondary Outcome

Title	Hemoglobin Concentration by Visit
Time Frame	Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21

Outcome Measure Data

Analysis Population Description

Primary analysis set includes all enrolled participants who received at least 1 dose of investigational product. The number of participants with available data at each time point is indicated by "n".

Arm/Group Title	Peginesatide
Arm/Group Description	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Measure Participants	34
Baseline (n=34)	10.51 (0.76)
Week 3 (n=34)	11.09 (0.81)
Week 5 (n=29)	10.86 (0.87)
Week 7 (n=21)	11.03 (1.02)
Week 9 (n=20)	10.59 (0.84)
Week 11 (n=19)	10.80 (0.97)
Week 13 (n=14)	10.50 (0.94)
Week 15 (n=10)	10.70 (0.82)
Week 17 (n=10)	10.35 (1.31)
Week 19 (n=10)	10.93 (0.94)
Week 21 (n=1)	10.10 (NA)
End of study visit (n=32)	10.55 (0.63)

4. Secondary Outcome

Title	Peginesatide Dose by Visit
Time Frame	Baseline and Weeks 5, 9, 13, and 17

Outcome Measure Data

Analysis Population Description

Primary analysis set, with available data at each time point (indicated by n)

Arm/Group Title	Peginesatide
Arm/Group Description	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Measure Participants	34
Baseline (n=30)	5.42 (2.48)
Week 5 (n=16)	5.04 (1.32)
Week 9 (n=15)	4.98 (2.00)
Week 13 (n=9)	4.00 (2.53)
Week 17 (n=9)	5.12 (3.29)

Adverse Events

Time Frame	From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
Adverse Event Reporting Description	The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Arm/Group Title	Peginesatide
Arm/Group Description	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
All Cause Mortality
	Peginesatide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Peginesatide
	Affected / at Risk (%)	# Events
Total	3/34 (8.8%)
Cardiac disorders
Ventricular asystole	1/34 (2.9%)
Gastrointestinal disorders
Small intestinal obstruction	1/34 (2.9%)
Hepatobiliary disorders
Cholelithiasis	1/34 (2.9%)
Infections and infestations
Gastroenteritis	1/34 (2.9%)
Pneumonia	1/34 (2.9%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/34 (2.9%)
Pulmonary oedema	1/34 (2.9%)
Other (Not Including Serious) Adverse Events
	Peginesatide
	Affected / at Risk (%)	# Events
Total	6/34 (17.6%)
General disorders
Oedema	2/34 (5.9%)
Nervous system disorders
Headache	2/34 (5.9%)
Vascular disorders
Hypertension	2/34 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.