Phase 2
N=210
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Anemia · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01906489 ↗Enrolled (actual)
210
Serious AEs
21.0%
Results posted
Jul 2022
Primary outcome: Primary: Percentage of Participants Achieving a Successful Hemoglobin Response — 54.9; 10.3 Percentage of participants — p==0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AKB-6548 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Akebia Therapeutics
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Successful Hemoglobin Response |
54.9; 10.3 | =0.0001 sig |
| SECONDARY Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study |
59.6; 88.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value |
44.9; 13.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group |
50; 7.9 | — |
| SECONDARY Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group |
41.5; 19 | =0.0953 |
| SECONDARY Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group |
33.3; 7.7 | =0.1238 |
| SECONDARY Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population |
44.1; 11.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Hemoglobin |
9.94; 9.96; 0.1; -0.22; 0.39; -0.25 | =0.0019 sig |
| SECONDARY Absolute Values of Hemoglobin |
9.94; 9.96; 10.02; 9.74; 10.35; 9.7 | — |
| SECONDARY Change From Baseline in Hematocrit |
30.4; 30.3; 0.8; -0.6; 2; -0.5 | <0.0001 sig |
| SECONDARY Absolute Values of Hematocrit |
30.4; 30.3; 31.2; 29.7; 32.4; 29.7 | — |
| SECONDARY Change From Baseline in Red Blood Cell Count |
3.38; 3.34; 0.02; -0.08; 0.12; -0.08 | =0.0031 sig |
| SECONDARY Absolute Values of Red Blood Cell Count |
3.38; 3.34; 3.39; 3.25; 3.51; 3.24 | — |
| SECONDARY Change From Baseline in Reticulocyte Count |
2.12; 1.97; 0.61; -0.07; 0.29; 0.06 | <0.0001 sig |
| SECONDARY Absolute Values of Reticulocyte Count |
2.12; 1.97; 2.74; 1.91; 2.44; 2.06 | — |
| SECONDARY Percentage of Participants Who Received ESA Rescue |
4.4; 12.5; 0; 4.2 | — |
| SECONDARY Mean Number of ESA Rescue Doses Administered Per Participant |
1.7; 2.8; 4.3 | — |
| SECONDARY Percentage of Participants Who Received Packed Red Blood Cell Transfusion Rescue |
0; 1.4 | — |
| SECONDARY Number of Packed Red Blood Cell Transfusion Administered Per Participant |
1.0 | — |
| SECONDARY Time to First Transfusion or ESA Rescue Medication Intake |
21.6; 21.2 | =0.0017 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) |
58; 29; 33; 11 | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Vital Signs |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings |
1; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings |
0; 0 | — |
Summary
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.
Eligibility Criteria
Key Inclusion Criteria
- 18 to 82 years of age, inclusive
- Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis
- eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2
- Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol
- Iron replete with ferritin and TSAT levels as defined per protocol
Key Exclusion Criteria
- BMI > 44.0 kg/m2
- Red blood cell transfusion within 11 weeks prior to the Screening visit
- Androgen therapy within the previous 21 days prior to the Screening visit
- Intravenous iron within the past 4 weeks prior to the Screening visit
- AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN
- Screening ECG with QTc > 500 msec
- Uncontrolled hypertension
- Class III or IV congestive heart failure
- Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit
Data sourced from ClinicalTrials.gov (NCT01906489). 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.