Trial Outcomes & Findings for Study of South African Dialysis Patients (NCT NCT01890577)

Results Overview

Due to the premature termination of the study no outcome measure data were analyzed.

Recruitment status

TERMINATED

Target enrollment

28 participants

Primary outcome timeframe

Each 4-week period for the duration of the study period (15 months)

Results posted on

2016-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Aranesp® Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
Overall Study STARTED	28
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of South African Dialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aranesp® n=28 Participants Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
Age, Continuous	55.8 years STANDARD_DEVIATION 15.1 • n=5 Participants
Gender Female	13 participants n=5 Participants
Gender Male	14 participants n=5 Participants
Race/Ethnicity, Customized White/caucasian	1 participants n=5 Participants
Race/Ethnicity, Customized Black	12 participants n=5 Participants
Race/Ethnicity, Customized Asian	11 participants n=5 Participants
Race/Ethnicity, Customized Colored	3 participants n=5 Participants
Baseline Hemoglobin Concentration	9.7 g/dL STANDARD_DEVIATION 2.0 • n=5 Participants
Baseline Aranesp Route Intravenous	1 participants n=5 Participants
Baseline Aranesp Route Subcutaneous	27 participants n=5 Participants
Baseline Aranesp Dose	36.6 µg/week STANDARD_DEVIATION 7.5 • n=5 Participants

PRIMARY outcome

Timeframe: Each 4-week period for the duration of the study period (15 months)

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over the 15-month observation period

Hemoglobin excursions defined as hemoglobin \<10g/dL and \>12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: On a continuous basis over the 15-month observation period

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over the 15-month observation period

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day of commencement of Aranesp

Ratio of the calculated mean weekly dose equivalent of an ESA administered immediately prior to conversion to treatment with Aranesp, to the calculated mean weekly dose equivalent of the first dose of Aranesp administered at commencement. Not applicable to participants who were ESA-naive at time of Aranesp commencement. Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over the 15-month observation period

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At each 12-week interval over the observation period

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over the 15-month observation period

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over the 15-month observation period

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Over the 15-month observation period

Due to the premature termination of the study no outcome measure data were analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Aranesp®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. 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.
Publication restrictions are in place

Restriction type: OTHER