Anemia Due to Chronic Kidney Disease
Conditions
Keywords
anemia, CKD, ESKD
Brief summary
This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)
Interventions
DRUGAND017 capsules
AND017 capsules administered orally with a starting dose of 10 mg TIW
DRUGESA
ESA injection and dose based on package insert and local practice
Sponsors
Kind Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription. * Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks * The mean of two hemoglobin values during screening must be 9.0-12.0 g/dL. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\<3× upper limit of normal (ULN) * Transferrin saturation ≥20% or ferritin ≥100 ng/mL at screening test * Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test Key
Exclusion criteria
* Concurrent retinal neovascular lesions requiring treatment * Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms * History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment * Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure \>180 mmHg, or diastolic blood pressure \>110 mmHg during the screening assessment * Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher) * History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment * Participants with a history of significant liver disease or active liver disease * History of a seizure disorder or any occurrence of seizures in the past * Serum albumin (ALB) \< 2.5 g/dL at screening test * Prior ESA/hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment caused total bilirubin \>1.5xULN, or AST/ALT/ ALP\>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) * Any prior functioning organ transplant or a scheduled organ transplantation, or anephric
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD | From Week 23 to Week 27 | The mean Hb levels averaged over Week 23-27 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of responders | From baseline to Week 27 | Responder is defined as: for participants with baseline Hb ≥ 9.0 g/dL, mean Hb ≥10.0 g/dL and a change from baseline ≥ -1.0 g/dL during Weeks 23-27 |
| Percentage of participants that maintained Hb level over target lower limit | From Week 5 to Week 27 | Percentage of participants with mean Hb ≥ 10.0 g/dL averaged over Weeks 5-27 |
| Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period. | From baseline to Week 53 | During entire study treatment period, the percentage of participants in which Hb, after first reaching ≥ 10.0 g/dL, is maintained within the target range of 10.0-12.0 g/dL (inclusive) |
| Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period | From baseline to Week 53 | During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g/dL or \< 7.5 g/dL |
| Incidence of excessive erythropoiesis | From baseline to Week 53 | During the entire study treatment period, the percentage of participants with an Hb increase ≥ 1.0 g/dL within any 2-week period and an Hb increase ≥ 2.0 g/dL within any 4-week period respectively |
| The cumulative incidence of Hb non-response | From baseline to Week 27 | The cumulative incidence of Hb non-response is defined as Hb \< 10.0 g/dL and an increase from baseline \< 1.0 g/dL averaged over Weeks 5-27 |
| Mean Hb change from baseline averaged over Weeks 5-27 | From baseline to Week 27 | Mean Hb change from baseline averaged over Weeks 5-27 |
| Mean Hb change from baseline averaged over Weeks 23-27 | From baseline to Week 27 | Mean Hb change from baseline averaged over Weeks 23-27 |
| Mean Hb change from baseline averaged over Weeks 13-17 | From baseline to Week 17 | Mean Hb change from baseline averaged over Weeks 13-17 |
| Mean Hb change from baseline averaged over Weeks 27-53 | From baseline to Week 53 | Mean Hb change from baseline averaged over Weeks 27-53 |
| Mean Hb change from baseline averaged over Weeks 49-53 | Mean Hb change from baseline averaged over Weeks 49-53 | Mean Hb change from baseline averaged over Weeks 49-53 |
| During the entire treatment period, mean Hb at each visit | From baseline to Week 53 | During the entire treatment period, mean Hb at each visit |
| The use of intravenous iron during the entire study treatment period | From baseline to Week 53 | The percentage of participants that have received intravenous iron during the entire study treatment period |
| The mean weekly dose of intravenous iron during the entire treatment period | From baseline to Week 53 | The mean weekly dose of intravenous iron during the entire treatment period |
| The time to first initiation of intravenous iron during the entire treatment period | From baseline to Week 53 | The time to first initiation of intravenous iron during the entire treatment period |
Countries
China
Contacts
CONTACTYusha Zhu, MD, PhD
STUDY_DIRECTORYusha Zhu, MD, PhD
Kind Pharmaceuticals LLC
Outcome results
None listed