Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT01235936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2022-07-01
Summary
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
Conditions
Interventions
- DRUG
-
AKB-6548
Different dose levels
Sponsors & Collaborators
-
Akebia Therapeutics
lead INDUSTRY
Principal Investigators
-
Chief Medical Officer · Akebia Therapeutics Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-21
- Primary Completion
- 2011-04-13
- Completion
- 2011-05-31
Countries
- United States
Study Locations
More Related Trials
-
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
NCT02019719 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
NCT02243306 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment
NCT01406340 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
NCT05035641 ·Status: COMPLETED ·Phase: PHASE2
-
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
NCT02912533 ·Status: COMPLETED ·Phase: PHASE3
-
CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis
NCT03428594 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.
NCT01146574 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
NCT04059913 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function
NCT03546205 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
NCT01750190 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
NCT01978587 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis
NCT01999582 ·Status: COMPLETED ·Phase: PHASE2
-
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
NCT02805244 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis
NCT05265325 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia
NCT00609544 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis
NCT02174627 ·Status: COMPLETED ·Phase: PHASE3
-
Peginesatide for Anemia in Chronic Hemodialysis Patients
NCT00228449 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
NCT03054350 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
NCT02508506 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
NCT01971164 ·Status: COMPLETED ·Phase: PHASE1
-
A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients
NCT02570854 ·Status: COMPLETED ·Phase: PHASE1
-
PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function
NCT04656795 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis
NCT03612856 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
NCT03242967 ·Status: WITHDRAWN ·Phase: PHASE3
-
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
NCT03054337 ·Status: COMPLETED ·Phase: PHASE2