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

This study has been completed.
Sponsor:
Collaborator:
Affymax
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01478971
First received: November 22, 2011
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: February 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease
Anemia
Interventions: Drug: Epoetin
Drug: Peginesatide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 5 investigative sites in the United States from 11 October 2011 to 08 February 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with chronic kidney disease and on dialysis continued to receive their standard of care epoetin treatment for 6 months and then transitioned to receive peginesatide injection for 6 months.

Reporting Groups
  Description
Peginesatide Injection 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 a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).

Participant Flow for 2 periods

Period 1:   Standard of Care Period
    Peginesatide Injection  
STARTED     184  
Received Treatment     178  
COMPLETED     159  
NOT COMPLETED     25  
Adverse Event                 1  
Withdrawal by Subject                 3  
Death                 8  
Lost to Follow-up                 9  
Other                 4  

Period 2:   Peginesatide Treatment Period
    Peginesatide Injection  
STARTED     157 [1]
COMPLETED     143  
NOT COMPLETED     14  
Adverse Event                 1  
Withdrawal by Subject                 1  
Death                 4  
Lost to Follow-up                 4  
Other                 4  
[1] 2 participants terminated the study before transitioning to peginesatide for unknown reasons



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Peginesatide Injection 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 a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).

Baseline Measures
    Peginesatide Injection  
Number of Participants  
[units: participants]
  178  
Age  
[units: years]
Mean ± Standard Deviation
  59.6  ± 15.33  
Age, Customized  
[units: participants]
 
< 65 years     103  
65 - 74 years     44  
≥ 75 years     31  
Gender  
[units: participants]
 
Female     84  
Male     94  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic or Latino     76  
Not Hispanic or Latino     102  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     10  
Black     43  
Native Hawaiian or Other Pacific Islander     5  
White     119  
Region of Enrollment  
[units: participants]
 
United States     178  
Weight [1]
[units: kg]
Mean ± Standard Deviation
  83.8  ± 22.93  
Time on dialysis  
[units: years]
Mean ± Standard Deviation
  4.2  ± 3.71  
Kidney transplant recipient  
[units: participants]
 
Yes     17  
No     161  
Nephrotic syndrome history  
[units: participants]
 
Yes     30  
No     148  
Primary cause of chronic kidney disease  
[units: participants]
 
Diabetes     97  
Hypertension     37  
Cystic renal disease     6  
Interstitial nephritis     2  
Glomerulonephritis     15  
Urological     4  
Immunoglobulin (Ig) A nephropathy     3  
Congenital     1  
Unknown     3  
Other     10  
Current dialysis frequency  
[units: participants]
 
2 times a week     3  
3 times a week     169  
4 times a week     4  
5 times a week     1  
6 times a week     1  
Baseline hemoglobin  
[units: g/dL]
Mean ± Standard Deviation
  10.9  ± 0.96  
Ferritin [2]
[units: ng/mL]
Mean ± Standard Deviation
  1068.7  ± 513.1  
Transferrin saturation [3]
[units: percent┬ásaturation]
Mean ± Standard Deviation
  35.2  ± 13.85  
[1] Weight data only available for 177 participants.
[2] Ferritin data only available for 149 participants.
[3] Transferrin saturation data only available for 146 participants.



  Outcome Measures
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1.  Primary:   Percentage of Participants Undergoing Conversion to Peginesatide Injection   [ Time Frame: 6 months ]

2.  Secondary:   Peginesatide Dosing   [ Time Frame: Month 6 - 12 ]

3.  Secondary:   Peginesatide Dose Deviations   [ Time Frame: Months 6 - 12 ]

4.  Secondary:   Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL   [ Time Frame: Months 1, 2, 3, 4, 5 and 6 of each treatment period ]

5.  Secondary:   Percentage of Participants Who Received at Least One Intravenous Iron Dose   [ Time Frame: 12 months ]

6.  Secondary:   Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01478971     History of Changes
Other Study ID Numbers: AFX01-18
Study First Received: November 22, 2011
Results First Received: February 6, 2014
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board