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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: September 16, 2016
Last verified: September 2016
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 
Overall Participants Analyzed 
[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) 
[1] Weight data only available for 177 participants.
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 [1] 
[Units: ng/mL]
Mean (Standard Deviation)
 1068.7  (513.1) 
[1] Ferritin data only available for 149 participants.
Transferrin saturation [1] 
[Units: Percent saturation]
Mean (Standard Deviation)
 35.2  (13.85) 
[1] 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



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01478971     History of Changes
Other Study ID Numbers: AFX01-18
U1111-1150-2575 ( Registry Identifier: WHO )
Study First Received: November 22, 2011
Results First Received: February 6, 2014
Last Updated: September 16, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board