Loading clinical trials...

Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4

NCT01235936•Akebia Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to 79 years of age, inclusive
•Chronic Kidney Disease Stage 3 or Stage 4
•Hemoglobin (Hgb) \< 10.5 g/dl
•TSAT \> 20% and CBC indicating normocytic red blood cell morphology

Exclusion Criteria

•BMI \> 40
•Red blood cell transfusion within 12 weeks.
•Androgen therapy within the previous 21 days prior to study dosing
•Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
•Participants meeting the criteria of ESA resistance within the previous 4 months
•Individual doses of intravenous iron of 250 mg or larger within the past 21 days
•AST or ALT \>1.8x ULN.
•Alkaline phosphatase \>2x ULN.
•Total bilirubin \>1.5x ULN.
•Uncontrolled hypertension
+2 more criteria

Locations (2)

Augusta, Georgia, United States

San Antonio, Texas, United States

Key Dates

Start Date

October 21, 2010

Primary Completion Date

April 13, 2011

Completion Date

May 1, 2011

Last Updated

July 1, 2022

Enrollment

ACTUAL participants

Conditions

AnemiaKidney Disease

Interventions

AKB-6548

DRUG

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

View study

RECRUITING

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

NCT05012111

Severe Aplastic AnemiaTelomere Biology Disorders+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease