Phase 2
Completed N=61
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001
Source: ClinicalTrials.gov NCT02868229 ↗Enrolled (actual)
61
Serious AEs
32.8%
Results posted
Jul 2021
Primary outcomePrimary: Characterization of Maximum Tolerated Dose (MTD) — 0; 0; 0; 0 Events
Summary
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characterization of Maximum Tolerated Dose (MTD) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change in High-sensitivity C-reactive Protein (hsCRP): Week 4 |
0.373; -10.383; -11.981; -14.561 | 0.002 sig |
| PRIMARY Change in Serum Amyloid A (SAA): Week 4 |
-3.733; -22.056; -9.878; -31.910 | — |
| SECONDARY Number of Adverse Events of Special Interest |
0; 0; 0; 0 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
33; 51; 83; 66 | — |
| SECONDARY Electrocardiogram (ECG) |
5; 7; 4; 7; 1; 1 | — |
| SECONDARY Number of Participants Who Developed Anti-drug Antibodies (ADAs) |
2; 2; 1; 4; 10; 14 | — |
| SECONDARY Number of Participants With ADA Titers |
2; 2; 1; 4 | — |
| SECONDARY Number of Participants With Neutralizing ADAs |
0; 0; 0; 0 | — |
| SECONDARY Change in Transferrin Saturation (TSAT): Week 4 |
0.467; 5.622; 1.806; 15.778 | — |
| SECONDARY Change in TSAT: Mean of Weeks 10-12 |
2.278; 6.417; 9.167; 9.028 | — |
| SECONDARY Change in Reticulocyte Hemoglobin (CHr): Week 4 |
-0.265; 1.197; 1.188; 0.286 | — |
| SECONDARY Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks |
-0.021; -0.534; -0.916; -1.462 | — |
| SECONDARY Change in SAA: Mean of Weeks 10-12 |
-1.262; -24.323; -8.688; -30.324 | — |
| SECONDARY Change in Serum Pre-albumin: Mean of 10-12 Weeks |
0.273; 6.032; 8.571; 11.170 | — |
| SECONDARY Change in Albumin: Week 12 |
0.042; 0.122; 0.192; 0.336 | — |
| SECONDARY Change in Erythropoietin Resistance Index (ERI): Week 4 |
-1.444; -0.975; -3.175; -4.211 | — |
| SECONDARY Change in ERI: Mean of Weeks 8-12 |
-2.714; -5.689; -7.842; -8.787 | — |
| SECONDARY Change in ERI: Mean of Weeks 10-12 |
-2.112; -6.477; -8.272; -8.690 | — |
| SECONDARY Change in CHr: Mean of Weeks 10-12 |
-0.035; 0.859; 1.271; 1.143 | — |
| SECONDARY Change in Hemoglobin: Week 4 |
-0.043; 0.473; 0.805; 0.973 | — |
| SECONDARY Change in Hemoglobin: Mean of Weeks 10-12 |
-0.107; 0.848; 0.963; 0.772 | — |
| SECONDARY Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose |
0.352; 0.228; 0.627; 0.567 | — |
| SECONDARY Change in ERI: Week 12 |
-3.229; -6.381; -8.835; -8.690 | — |
| SECONDARY Change in ERI: Mean of Weeks 9-12 |
-2.320; -6.338; -8.293; -8.756 | — |
| SECONDARY Change in Hemoglobin: Week 12 |
0.130; 0.502; 0.806; 0.755 | — |
| SECONDARY Change in Hemoglobin: Week 24 |
-0.803; 0.154; -0.267; -0.079 | — |
| SECONDARY Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4 |
-0.043; 0.473; 0.805; 0.973 | — |
| SECONDARY Basophils: Week 12 |
0.03; 0.02; 0.04; 0.03 | — |
| SECONDARY Basophil: Week 24 |
0.05; 0.04; 0.08; 0.02 | — |
| SECONDARY Basophils to Leukocytes Ratio: Week 12 |
0.65; 0.45; 0.95; 0.87 | — |
| SECONDARY Basophils to Leukocytes Ratio: Week 24 |
0.62; 0.83; 1.29; 0.57 | — |
| SECONDARY Eosinophils: Week 12 |
0.16; 0.35; 0.18; 0.65 | — |
| SECONDARY Eosinophils: Week 24 |
0.19; 0.29; 0.30; 0.36 | — |
| SECONDARY Eosinophils to Leukocytes Ratio: Week 12 |
3.39; 5.56; 4.14; 7.32 | — |
| SECONDARY Eosinophils to Leukocytes Ratio: Week 24 |
3.49; 4.44; 5.32; 3.98 | — |
| SECONDARY Erythrocyte Mean Corpuscular Hemoglobin: Week 12 |
30.2; 31.3; 30.8; 31.2 | — |
| SECONDARY Erythrocyte Mean Corpuscular Hemoglobin: Week 24 |
29.5; 31.0; 30.6; 29.6 | — |
| SECONDARY Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12 |
30.86; 31.41; 29.75; 31.23 | — |
| SECONDARY Erythrocyte Mean Corpuscular HGB Concentration: Week 24 |
30.78; 31.04; 29.52; 30.28 | — |
| SECONDARY Erythrocyte Mean Corpuscular Volume: Week 12 |
98.16; 99.35; 103.49; 99.97 | — |
| SECONDARY Erythrocyte Mean Corpuscular Volume: Week 24 |
95.70; 99.69; 103.53; 97.76 | — |
| SECONDARY Erythrocytes: Week 12 |
3.464; 3.348; 3.459; 3.370 | — |
| SECONDARY Erythrocytes: Week 24 |
3.312; 3.256; 3.111; 3.365 | — |
| SECONDARY Hematocrit: Week 12 |
34.0; 33.1; 35.6; 33.7 | — |
| SECONDARY Hematocrit: Week 24 |
31.5; 32.4; 32.2; 32.8 | — |
| SECONDARY Hemoglobin: Week 12 |
10.51; 10.37; 10.56; 10.53 | — |
| SECONDARY Hemoglobin: Week 24 |
9.68; 10.06; 9.47; 9.87 | — |
| SECONDARY Hypochromatic Red Cells Week 12 |
13.65; 12.09; 23.65; 11.99 | — |
| SECONDARY Hypochromatic Red Cells: Week 24 |
11.88; 11.60; 32.02; 15.44 | — |
| SECONDARY Leukocytes: Week 12 |
5.23; 5.84; 4.68; 5.25 | — |
| SECONDARY Leukocytes: Week 24 |
5.52; 6.06; 5.52; 6.13 | — |
| SECONDARY Lymphocytes: Week 12 |
1.10; 1.45; 1.11; 1.18 | — |
| SECONDARY Lymphocytes: Week 24 |
1.10; 1.26; 1.08; 1.23 | — |
| SECONDARY Lymphocytes to Leukocytes Ratio: Week 12 |
22.86; 25.09; 24.15; 24.81 | — |
| SECONDARY Lymphocytes to Leukocytes Ratio at Week 24 |
21.47; 21.24; 20.63; 21.71 | — |
| SECONDARY Monocytes: Week 12 |
0.26; 0.29; 0.25; 0.31 | — |
| SECONDARY Monocytes: Week 24 |
0.40; 0.39; 0.31; 0.30 | — |
| SECONDARY Monocytes to Leukocytes Ratio: Week 12 |
5.61; 5.42; 5.15; 6.21 | — |
| SECONDARY Monocytes to Leukocytes Ratio: Week 24 |
7.04; 6.29; 5.49; 5.77 | — |
| SECONDARY Neutrophils: Week 12 |
3.68; 3.70; 3.09; 3.09 | — |
| SECONDARY Neutrophils: Week 24 |
3.82; 4.08; 3.71; 4.25 | — |
| SECONDARY Neutrophils to Leukocytes Ratio: Week 12 |
67.29; 62.41; 65.61; 60.79 | — |
| SECONDARY Neutrophils to Leukocytes Ratio: Week 24 |
67.37; 67.21; 67.31; 67.94 | — |
| SECONDARY Platelets: Week 12 |
169.8; 168.3; 129.4; 143.8 | — |
| SECONDARY Platelets: Week 24 |
180.2; 203.1; 151.6; 160.1 | — |
| SECONDARY Reticulocytes to Erythrocytes Ratio: Week 12 |
1.92; 1.68; 2.14; 2.32 | — |
| SECONDARY Reticulocytes to Erythrocytes Ratio: Week 24 |
1.95; 1.96; 1.84; 2.24 | — |
| SECONDARY Alanine Aminotransferase: Week 12 |
12.1; 18.6; 19.9; 19.0 | — |
| SECONDARY Alanine Aminotransferase: Week 24 |
8.7; 11.9; 15.3; 15.4 | — |
| SECONDARY Albumin: Week 12 |
3.96; 3.90; 3.97; 3.98 | — |
| SECONDARY Albumin: Week 24 |
3.75; 3.83; 3.77; 3.84 | — |
| SECONDARY Alkaline Phosphatase: Week 12 |
103.0; 125.4; 107.5; 106.2 | — |
| SECONDARY Alkaline Phosphatase: Week 24 |
99.8; 140.6; 121.2; 95.2 | — |
| SECONDARY Aspartate Aminotransferase: Week 12 |
15.5; 18.1; 20.5; 15.7 | — |
| SECONDARY Aspartate Aminotransferase: Week 24 |
14.7; 14.3; 17.3; 14.7 | — |
| SECONDARY Bicarbonate: Week 12 |
23.5; 23.1; 22.7; 25.5 | — |
| SECONDARY Bicarbonate: Week 24 |
23.3; 24.6; 22.4; 26.0 | — |
| SECONDARY Bilirubin: Week 12 |
0.490; 0.450; 0.603; 0.553 | — |
| SECONDARY Bilirubin: Week 24 |
0.450; 0.430; 0.565; 0.520 | — |
| SECONDARY Calcium: Week 12 |
8.89; 8.54; 8.90; 8.39 | — |
| SECONDARY Calcium: Week 24 |
8.73; 8.95; 8.76; 8.82 | — |
| SECONDARY Chloride: Week 12 |
97.0; 98.6; 98.0; 98.5 | — |
| SECONDARY Chloride: Week 24 |
98.5; 97.7; 98.7; 97.6 | — |
| SECONDARY Cholesterol: Week 12 |
140.4; 140.3; 145.9; 146.0 | — |
| SECONDARY Cholesterol: Week 24 |
130.5; 148.3; 131.2; 158.0 | — |
| SECONDARY Creatinine: Week 12 |
9.458; 9.616; 9.227; 10.115 | — |
| SECONDARY Creatinine: Week 24 |
9.086; 9.173; 9.027; 9.703 | — |
| SECONDARY Direct Bilirubin: Week 12 |
0.101; 0.098; 0.123; 0.118 | — |
| SECONDARY Direct Bilirubin: Week 24 |
0.105; 0.081; 0.124; 0.102 | — |
| SECONDARY Glucose: Week 12 |
123.1; 128.5; 119.6; 101.2 | — |
| SECONDARY Glucose: Week 24 |
129.5; 129.9; 142.4; 104.2 | — |
| SECONDARY High-density Lipoprotein (HDL) Cholesterol: Week 12 |
51.6; 50.1; 54.2; 52.5 | — |
| SECONDARY HDL Cholesterol: Week 24 |
50.5; 45.4; 48.8; 46.8 | — |
| SECONDARY Hepcidin-25: Week 12 |
310.67; 344.99; 288.72; 233.89 | — |
| SECONDARY Hepcidin-25: Week 24 |
347.55; 328.35; 302.72; 262.18 | — |
| SECONDARY Low-density Lipoproteins (LDL) Cholesterol: Week 12 |
67.2; 61.4; 63.8; 68.1 | — |
| SECONDARY LDL Cholesterol: Week 24 |
60.9; 69.4; 54.7; 82.7 | — |
| SECONDARY Lipoprotein-a: Week 12 |
35.2; 86.3; 68.9; 53.1 | — |
| SECONDARY Lipoprotein-a: Week 24 |
39.3; 96.6; 89.5; 61.9 | — |
| SECONDARY Phosphate: Week 12 |
5.06; 5.67; 6.51; 5.43 | — |
| SECONDARY Phosphate: Week 24 |
5.55; 4.57; 5.15; 5.64 | — |
| SECONDARY Potassium: Week 12 |
5.13; 5.06; 5.03; 4.69 | — |
| SECONDARY Potassium: Week 24 |
4.96; 4.97; 4.71; 4.75 | — |
| SECONDARY Sodium: Week 12 |
135.8; 137.1; 137.4; 138.6 | — |
| SECONDARY Sodium: Week 24 |
136.7; 136.2; 137.8; 137.2 | — |
| SECONDARY Triglycerides: Week 12 |
107.9; 140.8; 139.5; 126.7 | — |
| SECONDARY Triglycerides: Week 24 |
95.4; 166.9; 146.6; 142.9 | — |
| SECONDARY Urea Nitrogen: Week 12 |
61.7; 61.1; 53.3; 62.1 | — |
| SECONDARY Urea Nitrogen: Week 24 |
66.2; 59.9; 51.1; 59.6 | — |
| SECONDARY Pre-dialysis Body Mass Index (BMI): Week 12 |
28.952; 29.668; 32.150; 32.574 | — |
| SECONDARY Pre-infusion BMI: Week 11 |
29.337; 29.399; 31.290; 34.163 | — |
| SECONDARY Pre-dialysis Diastolic Blood Pressure: Week 12 |
84.8; 70.4; 84.2; 76.3 | — |
| SECONDARY Pre-dialysis Diastolic Blood Pressure: Week 24 |
76.9; 77.8; 74.0; 78.8 | — |
| SECONDARY Pre-infusion Diastolic Blood Pressure: Week 11 |
82.3; 66.6; 75.8; 78.7 | — |
| SECONDARY Pre-dialysis Heart Rate: Week 12 |
69.3; 71.1; 70.8; 76.9 | — |
| SECONDARY Pre-dialysis Heart Rate: Week 24 |
71.8; 78.0; 72.6; 78.9 | — |
| SECONDARY Pre-infusion Heart Rate: Week 11 |
67.1; 70.1; 65.7; 72.8 | — |
| SECONDARY Pre-dialysis Respiration Rate: Week 12 |
17.8; 17.9; 17.9; 18.1 | — |
| SECONDARY Pre-dialysis Respiration Rate: Week 24 |
16.6; 18.1; 18.3; 18.4 | — |
| SECONDARY Pre-infusion Respiration Rate: Week 11 |
18.1; 17.8; 18.1; 18.3 | — |
| SECONDARY Pre-dialysis Systolic Blood Pressure: Week 12 |
164.4; 143.8; 164.3; 151.4 | — |
| SECONDARY Pre-dialysis Systolic Blood Pressure: Week 24 |
149.4; 146.7; 157.6; 155.8 | — |
| SECONDARY Pre-infusion Systolic Blood Pressure: Week 11 |
161.2; 138.7; 144.0; 152.1 | — |
| SECONDARY Pre-dialysis Weight: Week 12 |
84.583; 82.162; 92.120; 96.213 | — |
| SECONDARY Pre-infusion Weight: Week 11 |
86.356; 83.433; 92.043; 91.217 | — |
| SECONDARY Pre-dialysis Temperature: Week 12 |
36.259; 36.435; 36.436; 36.490 | — |
| SECONDARY Pre-dialysis Temperature: Week 24 |
36.328; 36.440; 36.168; 36.361 | — |
| SECONDARY Pre-infusion Temperature: Week 11 |
36.182; 36.377; 36.187; 36.375 | — |
| SECONDARY Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001 |
11962; 40911; 118177 | — |
| SECONDARY Elimination Half-life in the Initial Phase (t 1/2,α) |
2.55; 1.98; 1.90 | — |
| SECONDARY Elimination Half-life in the Terminal Phase (t 1/2, z) |
51.44; 38.22; 40.93 | — |
| SECONDARY Maximum Serum Concentration (Cmax) |
378; 1368; 3584 | — |
| SECONDARY Impact of ADAs on Pharmacokinetics |
0.361 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Age greater than or equal to 18 years at the time of signing of the ICF.
- The patient agrees to comply with the contraception and reproduction restrictions of the study
- Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
- At least 2 ferritin values during Screening > 300 ng/mL
- At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)
EXCLUSION CRITERIA
- Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
- Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
- Actively treated or active malignancy
- Known or suspected occult or active bleeding
- Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study
Data sourced from ClinicalTrials.gov (NCT02868229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.