Trial Outcomes & Findings for Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease (NCT NCT04036253)
NCT ID: NCT04036253
Last Updated: 2025-03-20
Results Overview
Evaluate the efficacy of treatment with erythropoietin alfa through the measured changes in levels of hemoglobin from baseline value to the mean value of the 8 to 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus EPREX/ ERYPO®.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
12 weeks of treatment
Results posted on
2025-03-20
Participant Flow
Participant milestones
| Measure |
Eprex/Erypo
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
23
|
|
Overall Study
COMPLETED
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Three patients from the HEMAX group and four patients from the EPREX group did not complete the study procedures.
Baseline characteristics by cohort
| Measure |
Eprex/Erypo
n=20 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
23 Participants
n=23 Participants
|
43 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=43 Participants
|
|
Age, Continuous
|
60.5 years
n=20 Participants
|
64 years
n=23 Participants
|
61 years
n=43 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
17 Participants
n=23 Participants
|
32 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
6 Participants
n=23 Participants
|
11 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=20 Participants
|
23 Participants
n=23 Participants
|
43 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=43 Participants
|
|
Region of Enrollment
Argentina
|
17 participants
n=20 Participants
|
22 participants
n=23 Participants
|
39 participants
n=43 Participants
|
|
Region of Enrollment
Paraguay
|
3 participants
n=20 Participants
|
1 participants
n=23 Participants
|
4 participants
n=43 Participants
|
|
Hemoglobin blood level
|
9.56 g/dL
STANDARD_DEVIATION 0.60 • n=18 Participants • Three patients from the HEMAX group and four patients from the EPREX group did not complete the study procedures.
|
9.44 g/dL
STANDARD_DEVIATION 0.81 • n=22 Participants • Three patients from the HEMAX group and four patients from the EPREX group did not complete the study procedures.
|
9.50 g/dL
STANDARD_DEVIATION 0.72 • n=40 Participants • Three patients from the HEMAX group and four patients from the EPREX group did not complete the study procedures.
|
PRIMARY outcome
Timeframe: 12 weeks of treatmentPopulation: Per protocol analysis
Evaluate the efficacy of treatment with erythropoietin alfa through the measured changes in levels of hemoglobin from baseline value to the mean value of the 8 to 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus EPREX/ ERYPO®.
Outcome measures
| Measure |
Eprex/Erypo
n=20 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Efficacy Evaluation Through Change in Hemoglobin Levels
Baseline hemoglobin levels
|
9.56 Hemoglobin levels (g/dL)
Standard Deviation 0.60
|
9.44 Hemoglobin levels (g/dL)
Standard Deviation 0.81
|
|
Efficacy Evaluation Through Change in Hemoglobin Levels
Average hemoglobin levels between visits 8 and 12
|
11.05 Hemoglobin levels (g/dL)
Standard Deviation 0.74
|
11.11 Hemoglobin levels (g/dL)
Standard Deviation 1.11
|
|
Efficacy Evaluation Through Change in Hemoglobin Levels
Hemoglobin levels change between both times
|
1.49 Hemoglobin levels (g/dL)
Standard Deviation 0.99
|
1.66 Hemoglobin levels (g/dL)
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: 24 weeks of treatmentEvaluate the safety through the incidence of adverse events and adverse reactions asessed after 12 and 24 weeks of treatment (week 24 reported which includes those evaluated at week 12), comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.
Outcome measures
| Measure |
Eprex/Erypo
n=20 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.
Overall Adverse Events
|
23 Adverse Events
|
30 Adverse Events
|
|
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.
Serious Events
|
4 Adverse Events
|
4 Adverse Events
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: Patients were classified as non-responders when hemoglobin did not increase at least 1 g/dL regarding baseline during any of the first 12 weeks of treatment
Evaluate the efficacy of treatment with erythropoietin alfa through the percentage of responder patients (increase of Hb ≥ 1g/ dl) after 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.
Outcome measures
| Measure |
Eprex/Erypo
n=18 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=22 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Percentage of Responder Patients
Non-Responders
|
5.56 percentage of participants
|
4.55 percentage of participants
|
|
Percentage of Responder Patients
Responders
|
94.44 percentage of participants
|
95.45 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentEvaluate the percentage of transfusional requirements after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.
Outcome measures
| Measure |
Eprex/Erypo
n=20 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Percentage of Patients That Required Any Transfusion
|
5 Percentage of patients
|
0 Percentage of patients
|
SECONDARY outcome
Timeframe: Intragroup efficacy until week 12Evaluate the efficacy between arms (HEMAX® PFS and EPREX/ ERYPO®) of treatment with erythropoietin alfa through the change in the level of hemoglobin from baseline in every visit until the week 12 visit.
Outcome measures
| Measure |
Eprex/Erypo
n=20 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Change of Hemoglobin Level at Week 12 of Treatment
Baseline
|
9.56 Hemoglobin levels (g/dL)
Standard Deviation 0.60
|
9.44 Hemoglobin levels (g/dL)
Standard Deviation 0.81
|
|
Change of Hemoglobin Level at Week 12 of Treatment
Week 8 to 12
|
11.05 Hemoglobin levels (g/dL)
Standard Deviation 0.74
|
11.11 Hemoglobin levels (g/dL)
Standard Deviation 1.11
|
|
Change of Hemoglobin Level at Week 12 of Treatment
Change
|
1.49 Hemoglobin levels (g/dL)
Standard Deviation 0.99
|
1.66 Hemoglobin levels (g/dL)
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Intragroup efficacy until week 24Evaluate the efficacy between arms (HEMAX® PFS and EPREX/ ERYPO®) of the change from the twice - a - week doses in the titration phase to a weekly dose in the maintenance phase through the changes in the hemoglobin levels from week 12 to weeks 16, 20 and 24 of treatment
Outcome measures
| Measure |
Eprex/Erypo
n=15 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=19 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration
Week 12
|
11.08 Hemoglobin levels (g/dL)
Standard Deviation 0.9
|
11.16 Hemoglobin levels (g/dL)
Standard Deviation 0.8
|
|
Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration
Week 16
|
10.9 Hemoglobin levels (g/dL)
Standard Deviation 0.97
|
10.82 Hemoglobin levels (g/dL)
Standard Deviation 1.12
|
|
Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration
Week 20
|
10.51 Hemoglobin levels (g/dL)
Standard Deviation 0.90
|
10.71 Hemoglobin levels (g/dL)
Standard Deviation 1.09
|
|
Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration
Week 24
|
10.97 Hemoglobin levels (g/dL)
Standard Deviation 0.96
|
10.85 Hemoglobin levels (g/dL)
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: 12 and 24 weeks of treatmentAn anti-erythropoietin alfa antibody determination will be performed to evaluate treatment immunogenicity at week 12 and 24 visit
Outcome measures
| Measure |
Eprex/Erypo
n=20 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Incidence of Anti-drug Antibodies (Immunogenicity)
Week 24
|
0 Participants with positive result
|
1 Participants with positive result
|
|
Incidence of Anti-drug Antibodies (Immunogenicity)
Week 12
|
0 Participants with positive result
|
0 Participants with positive result
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentPopulation: The analysis was restricted to patients with available hepcidin samples at baseline, 12 weeks, and 24 weeks due to an unanticipated loss of samples.
Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.
Outcome measures
| Measure |
Eprex/Erypo
n=10 Participants
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=14 Participants
Receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Concentration of Hepcidin
Baseline
|
84.80 ng hepcidin/ml
Standard Deviation 67.67
|
74.21 ng hepcidin/ml
Standard Deviation 64.26
|
|
Concentration of Hepcidin
Week 12
|
107.80 ng hepcidin/ml
Standard Deviation 96.31
|
56.07 ng hepcidin/ml
Standard Deviation 55.62
|
|
Concentration of Hepcidin
Week 24
|
83.60 ng hepcidin/ml
Standard Deviation 58.29
|
60.93 ng hepcidin/ml
Standard Deviation 44.16
|
Adverse Events
Eprex/Erypo
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Hemax PFS
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eprex/Erypo
n=20 participants at risk
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 participants at risk
receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Renal and urinary disorders
Worsening of renal function
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
8.7%
2/23 • Number of events 3 • After 12 and 24 weeks of treatment
|
|
Vascular disorders
Foot ulcer
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
General disorders
Worsened condition
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
Other adverse events
| Measure |
Eprex/Erypo
n=20 participants at risk
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
Hemax PFS
n=23 participants at risk
receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.
There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Erythropoietin alfa: Prefilled syringes of erythropoietin
|
|---|---|---|
|
Cardiac disorders
Increased blood pressure
|
15.0%
3/20 • Number of events 3 • After 12 and 24 weeks of treatment
|
13.0%
3/23 • Number of events 3 • After 12 and 24 weeks of treatment
|
|
Cardiac disorders
Lower limb edema
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
8.7%
2/23 • Number of events 2 • After 12 and 24 weeks of treatment
|
|
Cardiac disorders
Hypervolemia
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Gastrointestinal disorders
Acute diarrhea
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 2 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Blood and lymphatic system disorders
Splenomegaly
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Metabolism and nutrition disorders
Increased lipids
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
8.7%
2/23 • Number of events 2 • After 12 and 24 weeks of treatment
|
|
Metabolism and nutrition disorders
Increased creatinine levels
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Metabolism and nutrition disorders
Increased potassium levels
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 2 • After 12 and 24 weeks of treatment
|
|
Metabolism and nutrition disorders
Hypovitaminosis D
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Infections and infestations
Acute bronchitis
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
8.7%
2/23 • Number of events 2 • After 12 and 24 weeks of treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Infections and infestations
Conjunctivitis
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Infections and infestations
Scabies
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Knee arthropathy
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Heel pain
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Nervous system disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Renal and urinary disorders
Renal cyst
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
General disorders
Increased body weight
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
General disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • After 12 and 24 weeks of treatment
|
0.00%
0/23 • After 12 and 24 weeks of treatment
|
|
Vascular disorders
Venous ulcer
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
|
Vascular disorders
Peripheral arterial disease
|
0.00%
0/20 • After 12 and 24 weeks of treatment
|
4.3%
1/23 • Number of events 1 • After 12 and 24 weeks of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place