Trial Outcomes & Findings for Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA (NCT NCT00680043)
NCT ID: NCT00680043
Last Updated: 2012-06-29
Results Overview
The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
Baseline and Weeks 21-28
Results posted on
2012-06-29
Participant Flow
Participant milestones
| Measure |
Peginesatide 0.04 mg/kg
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
37
|
38
|
|
Overall Study
COMPLETED
|
37
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
Peginesatide 0.04 mg/kg
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Patient Not Compliant With Study Reqs.
|
0
|
1
|
0
|
|
Overall Study
Renal Transplant
|
1
|
0
|
4
|
Baseline Characteristics
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
Baseline characteristics by cohort
| Measure |
Peginesatide 0.04 mg/kg
n=39 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
n=37 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
n=38 Participants
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age Continuous
|
48.8 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 14.16 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 13.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 21-28Population: Full Analysis Population
The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.
Outcome measures
| Measure |
Peginesatide 0.04 mg/kg
n=39 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
n=37 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
n=38 Participants
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Baseline [N=39, 37, 38]
|
9.34 g/dL
Standard Deviation 0.738
|
9.20 g/dL
Standard Deviation 0.701
|
9.07 g/dL
Standard Deviation 0.739
|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Evaluation Period [N=37, 37, 36]
|
11.45 g/dL
Standard Deviation 1.101
|
11.59 g/dL
Standard Deviation 0.943
|
11.49 g/dL
Standard Deviation 0.775
|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Change from Baseline [N=37, 37, 36]
|
2.15 g/dL
Standard Deviation 1.038
|
2.39 g/dL
Standard Deviation 0.974
|
2.41 g/dL
Standard Deviation 0.991
|
SECONDARY outcome
Timeframe: Weeks 1 to 28Population: Full Analysis Population
Outcome measures
| Measure |
Peginesatide 0.04 mg/kg
n=39 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
n=37 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
n=38 Participants
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods
|
0.026 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1 to 28Population: Full Analysis Population
A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks.
Outcome measures
| Measure |
Peginesatide 0.04 mg/kg
n=39 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
n=37 Participants
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
n=38 Participants
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods
|
0.923 percentage of participants
|
0.973 percentage of participants
|
1.0 percentage of participants
|
Adverse Events
Peginesatide 0.04 mg/kg
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Peginesatide 0.08 mg/kg
Serious events: 8 serious events
Other events: 26 other events
Deaths: 0 deaths
Epoetin Alfa
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginesatide 0.04 mg/kg
n=39 participants at risk
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
n=37 participants at risk
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
n=38 participants at risk
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Eye disorders
Vitreous haemorrhage
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
General disorders
Pyrexia
|
0.00%
0/39
|
0.00%
0/37
|
2.6%
1/38
|
|
Infections and infestations
Appendicitis
|
0.00%
0/39
|
0.00%
0/37
|
2.6%
1/38
|
|
Infections and infestations
Bronchitis
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Infections and infestations
Hepatitis C
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Infections and infestations
Pyelonephritis
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Infections and infestations
Sinusitis
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
7.7%
3/39
|
2.7%
1/37
|
5.3%
2/38
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/39
|
0.00%
0/37
|
2.6%
1/38
|
|
Injury, poisoning and procedural complications
Radius fracture
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Metabolism and nutrition disorders
Diabetic foot
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/39
|
0.00%
0/37
|
2.6%
1/38
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Vascular disorders
Diabetic vascular disorder
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Vascular disorders
Hypertension
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/38
|
Other adverse events
| Measure |
Peginesatide 0.04 mg/kg
n=39 participants at risk
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.08 mg/kg
n=37 participants at risk
Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Epoetin Alfa
n=38 participants at risk
Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.6%
1/39
|
2.7%
1/37
|
10.5%
4/38
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39
|
0.00%
0/37
|
5.3%
2/38
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
7.7%
3/39
|
2.7%
1/37
|
10.5%
4/38
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/39
|
5.4%
2/37
|
0.00%
0/38
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/39
|
0.00%
0/37
|
5.3%
2/38
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/39
|
5.4%
2/37
|
7.9%
3/38
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/38
|
|
General disorders
Catheter site inflammation
|
2.6%
1/39
|
5.4%
2/37
|
0.00%
0/38
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/38
|
|
Infections and infestations
Respiratory tract infection
|
7.7%
3/39
|
8.1%
3/37
|
2.6%
1/38
|
|
Infections and infestations
Influenza
|
0.00%
0/39
|
5.4%
2/37
|
2.6%
1/38
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/39
|
0.00%
0/37
|
13.2%
5/38
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
23.1%
9/39
|
10.8%
4/37
|
21.1%
8/38
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
12.8%
5/39
|
10.8%
4/37
|
15.8%
6/38
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/38
|
|
Investigations
Blood pressure increased
|
2.6%
1/39
|
8.1%
3/37
|
5.3%
2/38
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.6%
1/39
|
2.7%
1/37
|
5.3%
2/38
|
|
Investigations
Transaminases increased
|
2.6%
1/39
|
2.7%
1/37
|
5.3%
2/38
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
3/39
|
18.9%
7/37
|
15.8%
6/38
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.7%
3/39
|
5.4%
2/37
|
5.3%
2/38
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39
|
5.4%
2/37
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.6%
1/39
|
0.00%
0/37
|
5.3%
2/38
|
|
Nervous system disorders
Headache
|
7.7%
3/39
|
8.1%
3/37
|
13.2%
5/38
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
2.6%
1/39
|
2.7%
1/37
|
13.2%
5/38
|
|
Vascular disorders
Hypertension
|
23.1%
9/39
|
16.2%
6/37
|
13.2%
5/38
|
|
Vascular disorders
Hypotension
|
2.6%
1/39
|
2.7%
1/37
|
15.8%
6/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication of the primary safety and efficacy results will include data from all appropriate study sites. Either after the first multicenter publication, or following 36 months after the completion of the study, Investigators are free to publish; such publications may not contain Sponsor Confidential Information and may be subject to Sponsor review 60 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER