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Lo studio clinico NCT07494409 per Anemia Due to Chronic Kidney Disease è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia Fase III 300 Randomizzato In aperto
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La sperimentazione clinica NCT07494409 è uno studio interventistico di Fase III volto a esaminare il trattamento per Anemia Due to Chronic Kidney Disease, attualmente in arruolamento. Avviato il 31 ottobre 2025, prevede di arruolare 300 partecipanti. Sotto la guida di Kind Pharmaceuticals LLC, dovrebbe concludersi entro il 30 aprile 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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)
Titolo ufficiale
A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
Patologie
Anemia Due to Chronic Kidney DiseaseAltri ID dello studio
- AND017-CN-302
- CTR20253615 (Altro identificativo) (China National Medical Products Administration)
Numero NCT
Data di inizio (effettiva)
2025-10-31
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-04-30
Arruolamento (previsto)
300
Tipo di studio
Interventistico
FASE
Fase III
Stato
In arruolamento
Parole chiave
anemia
CKD
ESKD
CKD
ESKD
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleAND017 | AND017 capsules AND017 capsules administered orally with a starting dose of 10 mg TIW |
Comparatore attivoErythropoiesis Stimulating Agents (ESA) | ESA ESA injection and dose based on package insert and local practice |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD | The mean Hb levels averaged over Week 23-27 | From Week 23 to Week 27 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
The percentage of responders | 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 | From baseline to Week 27 |
Percentage of participants that maintained Hb level over target lower limit | Percentage of participants with mean Hb ≥ 10.0 g/dL averaged over Weeks 5-27 | From Week 5 to Week 27 |
Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period. | 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) | From baseline to Week 53 |
Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period | During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g/dL or \< 7.5 g/dL | From baseline to Week 53 |
Incidence of excessive erythropoiesis | 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 | From baseline to Week 53 |
The cumulative incidence of Hb non-response | 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 | From baseline to Week 27 |
Mean Hb change from baseline 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 23-27 | Mean Hb change from baseline averaged over Weeks 23-27 | From baseline to Week 27 |
Mean Hb change from baseline averaged over Weeks 13-17 | Mean Hb change from baseline averaged over Weeks 13-17 | From baseline to Week 17 |
Mean Hb change from baseline averaged over Weeks 27-53 | Mean Hb change from baseline averaged over Weeks 27-53 | From baseline to Week 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 | During the entire treatment period, mean Hb at each visit | From baseline to Week 53 |
The use of intravenous iron during the entire study treatment period | The percentage of participants that have received intravenous iron during the entire study treatment period | From baseline to Week 53 |
The mean weekly dose of intravenous iron during the entire treatment period | The mean weekly dose 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 | The time to first initiation of intravenous iron during the entire treatment period | From baseline to Week 53 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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
- 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
Kind Pharmaceuticals LLCContatti principali dello studio
Contatto: Yusha Zhu, MD, PhD, 6467252552, [email protected]
1 Centri dello studio in 1 paesi
Fudan Univeristy Zhongshan Hospital, Shanghai, 200032, China
Xiaoqiang Ding, Investigatore principale
In arruolamento