Trial Outcomes & Findings for Mechanisms of EPO-induced Hypertension (NCT NCT03810911)

Last Updated: 2025-12-15

Results Overview

Within group change in diastolic blood pressure from 12 weeks to 24 weeks compared to change in diastolic blood pressure from baseline to 12 weeks in the delayed start group

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

12 to 24 weeks compared to baseline to 12 weeks

Results posted on

2025-12-15

Participant Flow

Between 18 December 2020, and 22 September 2023, 1699 individuals were assessed for study eligibility. These individuals were screened, 4398 times for a mean of 2.6 times per person. In all, 281 (17%) were noted to be potentially eligible, of which, 157 (56%) agreed to come for a consent visit.

65 individuals (41%) consented, of which, 27 (42%) were enrolled in the trial and underwent randomization stratified by the level of albuminuria (KDIGO stage A1, A2, or A3). 16 were assigned to waitlisted and 11 to immediate start group. In each of the two groups, two patients did not complete the study. The most common reason for randomization failure was either Hgb out of range (39%) or ambulatory BP out of range (39%). The trial was stopped because of inability to reach target sample size.

Participant milestones

Participant milestones
Measure	Early Start Participants given study drug immediately at randomization	Delayed Start Participants given study drugs 12 weeks after randomization
Overall Study STARTED	11	16
Overall Study COMPLETED	9	14
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Start Participants given study drug immediately at randomization	Delayed Start Participants given study drugs 12 weeks after randomization
Overall Study Death	1	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Mechanisms of EPO-induced Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Start n=11 Participants Participants given study drug immediately at randomization	Delayed Start n=16 Participants Participants given study drugs 12 weeks after randomization	Total n=27 Participants Total of all reporting groups
Sex: Female, Male Female	1 Participants n=6009 Participants	4 Participants n=42 Participants	5 Participants n=77 Participants
Sex: Female, Male Male	10 Participants n=6009 Participants	12 Participants n=42 Participants	22 Participants n=77 Participants
Race/Ethnicity, Customized Self stated race · White	10 Participants n=6009 Participants	9 Participants n=42 Participants	19 Participants n=77 Participants
Race/Ethnicity, Customized Self stated race · Black	1 Participants n=6009 Participants	7 Participants n=42 Participants	8 Participants n=77 Participants
Weight -- kg (SD)	99.3 kg STANDARD_DEVIATION 19.7 • n=6009 Participants	88.5 kg STANDARD_DEVIATION 24.5 • n=42 Participants	92.9 kg STANDARD_DEVIATION 22.9 • n=77 Participants
Age, Customized Age - years (SD)	74.6 Years STANDARD_DEVIATION 6 • n=6009 Participants	75.1 Years STANDARD_DEVIATION 9.3 • n=42 Participants	74.9 Years STANDARD_DEVIATION 8 • n=77 Participants
Medical History Diabetes -- n (%)	8 Participants n=6009 Participants	9 Participants n=42 Participants	17 Participants n=77 Participants
Medical History Myocardial infarction -- n (%)	2 Participants n=6009 Participants	4 Participants n=42 Participants	6 Participants n=77 Participants
Medical History Stroke -- n (%)	1 Participants n=6009 Participants	1 Participants n=42 Participants	2 Participants n=77 Participants
Medical History Coronary revascularization -- n (%)	4 Participants n=6009 Participants	6 Participants n=42 Participants	10 Participants n=77 Participants
Medical History Heart failure hospitalization -- n (%)	5 Participants n=6009 Participants	5 Participants n=42 Participants	10 Participants n=77 Participants
Hemoglobin -- g/dL (SD)	9.4 g/dL STANDARD_DEVIATION 0.6 • n=6009 Participants	9.5 g/dL STANDARD_DEVIATION 0.7 • n=42 Participants	9.4 g/dL STANDARD_DEVIATION 0.6 • n=77 Participants
Serum ferritin -- ng/mL (25th-75th percentile)	110 ng/mL n=6009 Participants	91 ng/mL n=42 Participants	95 ng/mL n=77 Participants
Transferrin saturation -- percent (SD)	21 % STANDARD_DEVIATION 9.8 • n=6009 Participants	24.2 % STANDARD_DEVIATION 15.5 • n=42 Participants	23 % STANDARD_DEVIATION 13.3 • n=77 Participants
Baseline eGFR -- mL/min/1.73m^2 (SD)	38.6 mL/min/1.73m^2 STANDARD_DEVIATION 11.7 • n=6009 Participants	36 mL/min/1.73m^2 STANDARD_DEVIATION 13.9 • n=42 Participants	37.1 mL/min/1.73m^2 STANDARD_DEVIATION 12.9 • n=77 Participants
Glomerular filtration rate (GFR) category (G1-G5) G2 -- n (%)	0 Participants n=6009 Participants	1 Participants n=42 Participants	1 Participants n=77 Participants
Baseline clinic blood pressure Clinic systolic blood pressure -- mmHg (SD)	125.1 mmHg STANDARD_DEVIATION 22.1 • n=6009 Participants	123.2 mmHg STANDARD_DEVIATION 15.8 • n=42 Participants	124.4 mmHg STANDARD_DEVIATION 19.5 • n=77 Participants
Baseline clinic blood pressure Clinic diastolic blood pressure -- mmHg (SD)	58.5 mmHg STANDARD_DEVIATION 12.1 • n=6009 Participants	55.4 mmHg STANDARD_DEVIATION 10.6 • n=42 Participants	57.2 mmHg STANDARD_DEVIATION 11.4 • n=77 Participants
Glomerular filtration rate (GFR) category (G1-G5) G3a -- n (%)	5 Participants n=6009 Participants	3 Participants n=42 Participants	8 Participants n=77 Participants
Glomerular filtration rate (GFR) category (G1-G5) G3b -- n (%)	4 Participants n=6009 Participants	6 Participants n=42 Participants	10 Participants n=77 Participants
Glomerular filtration rate (GFR) category (G1-G5) G4 -- n (%)	2 Participants n=6009 Participants	6 Participants n=42 Participants	8 Participants n=77 Participants
Albuminuria category (A1-A3) A1 -- n (%)	4 Participants n=6009 Participants	5 Participants n=42 Participants	9 Participants n=77 Participants
Albuminuria category (A1-A3) A2 -- n (%)	5 Participants n=6009 Participants	8 Participants n=42 Participants	13 Participants n=77 Participants
Albuminuria category (A1-A3) A3 -- n (%)	2 Participants n=6009 Participants	3 Participants n=42 Participants	5 Participants n=77 Participants
Baseline UACR -- mg/g creatinine median (25th-75th)	39 mg/g n=6009 Participants	79 mg/g n=42 Participants	56 mg/g n=77 Participants
Antihypertensive drugs -- n (SD)	3.5 Drugs STANDARD_DEVIATION 1.2 • n=6009 Participants	3 Drugs STANDARD_DEVIATION 1.2 • n=42 Participants	3.2 Drugs STANDARD_DEVIATION 1.2 • n=77 Participants
Nature of antihypertensive drugs ACE inhibitors or ARBs -- n (%)	7 Participants n=6009 Participants	6 Participants n=42 Participants	13 Participants n=77 Participants
Nature of antihypertensive drugs K sparing diuretics -- n (%)	2 Participants n=6009 Participants	3 Participants n=42 Participants	5 Participants n=77 Participants
Nature of antihypertensive drugs Loop diuretics -- n (%)	5 Participants n=6009 Participants	4 Participants n=42 Participants	9 Participants n=77 Participants
Nature of antihypertensive drugs Thiazide diuretics -- n (%)	4 Participants n=6009 Participants	4 Participants n=42 Participants	8 Participants n=77 Participants
Nature of antihypertensive drugs Dihydropyridine Ca channel blockers -- n (%)	6 Participants n=6009 Participants	9 Participants n=42 Participants	15 Participants n=77 Participants
Nature of antihypertensive drugs Nondihydropyridine Ca channel blockers -- n (%)	1 Participants n=6009 Participants	0 Participants n=42 Participants	1 Participants n=77 Participants
Nature of antihypertensive drugs Beta blockers -- n (%)	7 Participants n=6009 Participants	14 Participants n=42 Participants	21 Participants n=77 Participants
Nature of antihypertensive drugs Alpha blockers -- n (%)	5 Participants n=6009 Participants	3 Participants n=42 Participants	8 Participants n=77 Participants
Nature of antihypertensive drugs Vasodilators -- n (%)	1 Participants n=6009 Participants	5 Participants n=42 Participants	6 Participants n=77 Participants
Clinic heart rate -- beats per minute (SD)	71 beats per minutes STANDARD_DEVIATION 8 • n=6009 Participants	65 beats per minutes STANDARD_DEVIATION 10 • n=42 Participants	68 beats per minutes STANDARD_DEVIATION 9 • n=77 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

In the delayed start group (the control group), the investigators will measure the change in diastolic blood pressure from 0 weeks to 12 weeks compared to the change in diastolic BP from 0 to 12 weeks in the immediate start group.

Outcome measures

Outcome measures
Measure	Early Start n=11 Participants Participants given study drug immediately at randomization	Delayed Start n=16 Participants Participants given study drugs 12 weeks after randomization	24 Weeks (12-week Darbepoetin Exposure) Data from delayed start group baseline to 24 weeks (12-week darbepoetin exposure)
Change in Diastolic Blood Pressure in EPO Treated Patients Compared to Delayed Start Controls	1.4 mmHg Interval -1.8 to 4.6	-0.5 mmHg Interval -4.7 to 3.8	—

PRIMARY outcome

Timeframe: 12 to 24 weeks compared to baseline to 12 weeks

Within group change in diastolic blood pressure from 12 weeks to 24 weeks compared to change in diastolic blood pressure from baseline to 12 weeks in the delayed start group

Outcome measures

Outcome measures
Measure	Early Start n=16 Participants Participants given study drug immediately at randomization	Delayed Start n=14 Participants Participants given study drugs 12 weeks after randomization	24 Weeks (12-week Darbepoetin Exposure) Data from delayed start group baseline to 24 weeks (12-week darbepoetin exposure)
Within Group Change in Diastolic Blood Pressure in the Delayed Start Group	-1.9 mmHg Interval -5.4 to 1.6	3.2 mmHg Interval -0.5 to 6.8	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

In the delayed start group (the control group), the investigators will measure the change in systolic blood pressure change from 0 weeks to 12 weeks compared to the change in systolic BP from 0 to 12 weeks in the immediate start group.

Outcome measures

Outcome measures
Measure	Early Start n=11 Participants Participants given study drug immediately at randomization	Delayed Start n=16 Participants Participants given study drugs 12 weeks after randomization	24 Weeks (12-week Darbepoetin Exposure) Data from delayed start group baseline to 24 weeks (12-week darbepoetin exposure)
Change in Systolic Blood Pressure in EPO Treated Patients Compared to Delayed Start Controls	2 mmHg Interval -3.9 to 7.9	-3.6 mmHg Interval -11.5 to 4.3	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Worsening of hypertension at any time point will be defined as either an increase in blood pressure medication, an increase in seated clinic diastolic blood pressure by greater than or equal to 10 mmHg or systolic blood pressure increase of greater than or equal to 20 mmHg. Between-group change in hypertension status from baseline to 12 weeks will be compared in the immediate start and delayed start groups.

Outcome measures

Outcome measures
Measure	Early Start n=11 Participants Participants given study drug immediately at randomization	Delayed Start n=16 Participants Participants given study drugs 12 weeks after randomization	24 Weeks (12-week Darbepoetin Exposure) Data from delayed start group baseline to 24 weeks (12-week darbepoetin exposure)
Number of Participants With Worsened Hypertension Status in Immediate Start Group Compared to Delayed Start Controls	3 Participants	7 Participants	—

SECONDARY outcome

Timeframe: baseline to 12 weeks vs 12 weeks to 24 weeks

Worsening of hypertension at any time point will be defined as either an increase in blood pressure medication, an increase in seated clinic diastolic blood pressure by greater than or equal to 10 mmHg or systolic blood pressure increase of greater than or equal to 20 mmHg. Within-group change in hypertension status from 12 weeks to 24 weeks will be compared to the control period of 0 weeks to 12 weeks in the delayed start group.

Outcome measures

Outcome measures
Measure	Early Start n=16 Participants Participants given study drug immediately at randomization	Delayed Start n=16 Participants Participants given study drugs 12 weeks after randomization	24 Weeks (12-week Darbepoetin Exposure) Data from delayed start group baseline to 24 weeks (12-week darbepoetin exposure)
Number of Participants With Worsened Hypertension Status in Delayed Start Group Participants When They Were Not on EPO Compared to When They Were on EPO	7 Participants	7 Participants	—

SECONDARY outcome

Timeframe: Baseline to 4 weeks

The investigators used the high-resolution ultrasound of brachial artery to assess flow-mediated dilatation (FMD). FMD measures the dilation of blood vessels in response to increased blood flow and is the reference standard for assessing endothelial function. The mean percentage change in endothelial function of those treated with EPO were compared to that of the delayed start group. The hypothesis being tested is that EPO will cause impairment in endothelial function.

Outcome measures

Outcome measures
Measure	Early Start n=11 Participants Participants given study drug immediately at randomization	Delayed Start n=16 Participants Participants given study drugs 12 weeks after randomization	24 Weeks (12-week Darbepoetin Exposure) Data from delayed start group baseline to 24 weeks (12-week darbepoetin exposure)
Change in Endothelial Function in Those Treated With EPO Compared to the Waitlisted Group	0.9 percentage of endothelial function Interval -3.0 to 4.8	-1.2 percentage of endothelial function Interval -4.0 to 1.6	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks, baseline to 20 weeks, and baseline to 24 weeks

Change in urine albumin to urine creatinine ratio in the delayed start group baseline to 16 weeks (which is 4 weeks of exposure to darbepoetin), from baseline to 20 weeks (8-week exposure), and from baseline to 24 weeks (12-week exposure)

Outcome measures

Outcome measures
Measure	Early Start n=16 Participants Participants given study drug immediately at randomization	Delayed Start n=16 Participants Participants given study drugs 12 weeks after randomization	24 Weeks (12-week Darbepoetin Exposure) n=16 Participants Data from delayed start group baseline to 24 weeks (12-week darbepoetin exposure)
Change in Urine Albumin to Urine Creatinine Ratio in the Delayed Start Group	22 percentage change in UACR from baseline Interval 0.0 to 65.0	22 percentage change in UACR from baseline Interval 0.0 to 49.0	35 percentage change in UACR from baseline Interval 11.0 to 82.0

Adverse Events

Darbepoetin

Serious events: 8 serious events

Other events: 6 other events

Deaths: 2 deaths

No Darbepoetin

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Darbepoetin n=27 participants at risk Data from participants that were actively taking darbepoetin at the time of collection	No Darbepoetin n=16 participants at risk Data from participants that were not taking darbepoetin at the time of collection
General disorders Falls	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Cardiac disorders Congestive heart failure	11.1% 3/27 • Number of events 4 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Cardiac disorders Arrhythmia	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	12.5% 2/16 • Number of events 2 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Cardiac disorders Hypertensive crisis	7.4% 2/27 • Number of events 2 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Cardiac disorders Peripheral vascular disorder	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Nervous system disorders Seizures	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Blood and lymphatic system disorders Venous thromboembolism	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Infections and infestations Empyema	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Renal and urinary disorders Abnormal renal labs	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Gastrointestinal disorders GI bleed	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
General disorders Right leg weakness following cardiac catheterization	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
General disorders Unfit living conditions	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Infections and infestations Acute cholecystitis	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.

Other adverse events

Other adverse events
Measure	Darbepoetin n=27 participants at risk Data from participants that were actively taking darbepoetin at the time of collection	No Darbepoetin n=16 participants at risk Data from participants that were not taking darbepoetin at the time of collection
General disorders Falls	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 2 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Skin and subcutaneous tissue disorders Skin irritation or rash	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	12.5% 2/16 • Number of events 2 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Gastrointestinal disorders Diarrhea	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Infections and infestations Cellulitis	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Musculoskeletal and connective tissue disorders Musculoskeletal injury	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
General disorders Hypoglycemia	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Renal and urinary disorders Hyperkalemia	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
General disorders Delerium	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Infections and infestations Urinary tract infection	3.7% 1/27 • Number of events 2 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Renal and urinary disorders Kidney transplant hydronephrosis	0.00% 0/27 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Gastrointestinal disorders Constipation	7.4% 2/27 • Number of events 2 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	6.2% 1/16 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.
Gastrointestinal disorders Gastroenteritis	3.7% 1/27 • Number of events 1 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.	0.00% 0/16 • through study completion, at most 6 months Harms will be assessed by monitoring changes in weight, eGFR, CBC, clinic BP, and ABPM. Safety of continued participation will be assessed at each study visit. The stop-points will be treatment-emergent severe adverse events that precludes further exposure to the drug, such as an allergic drug reaction, initiation of renal replacement therapy, or death. If the study drug is stopped, the subject will be continued to be studied so as to not violate the intention-to-treat principle.

Additional Information

Dr. Rajiv Agarwal MD MS

Richard L. Roudebush Veterans Affairs Medical Center

Phone: (317) 988-2241

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place