| Trial ID: | L0388 |
| Source ID: | NCT01478971
|
| Associated Drug: |
Epoetin
|
| Title: |
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
|
| Acronym: |
DIAMOND
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01478971/results
|
| Conditions: |
Chronic Kidney Disease|Anemia
|
| Interventions: |
DRUG: Epoetin|DRUG: Peginesatide
|
| Outcome Measures: |
Primary: Percentage of Participants Undergoing Conversion to Peginesatide Injection, 6 months | Secondary: Peginesatide Dosing, The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide., Month 6 - 12|Peginesatide Dose Deviations, Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data., Months 6 - 12|Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL, Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 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, Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores., 12 months|Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Takeda | Collaborators: Affymax
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
184
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-10
|
| Completion Date: |
2013-02
|
| Results First Posted: |
2014-05-26
|
| Last Update Posted: |
2016-09-20
|
| Locations: |
Research Facility, Sacramento, California, 95825, United States|Research Facility, San Diego, California, 91910, United States|Research Facility, San Jose, California, 95128, United States|Research Facility, North Brunswick, New Jersey, 08902, United States|Research Facility, San Antonio, Texas, 78215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01478971
|
