Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01906489 · ClinicalTrials.gov registry record · Phase 2
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
A Phase 2 study of Chronic Kidney Disease and Anemia, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT01906489: Completed Phase 2 study of Chronic Kidney Disease and Anemia, sponsored by Akebia Therapeutics.
NCT01906489 is a Phase 2 study of Chronic Kidney Disease and Anemia that has completed, run by Akebia Therapeutics. The registered enrollment target is 210 participants, below the 3,205-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01906489, a Phase 2 study of Chronic Kidney Disease and Anemia, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Hemoglobin (Hgb) response was defined as participants with mean Hgb ≥11.0 grams per deciliter (g/dL) (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving Erythropoiesis-Stimulating Agents (ESA) or transfusion.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AKB-6548
Study Locations (20)
California
- - Azusa
- - Chula Vista
- - Downey
- - El Centro
- - La Mesa
- - Long Beach
- - Riverside
- - Sacramento
- - San Diego
Florida
- - Lauderdale Lakes
- - Port Charlotte
- - Tampa
Arizona
- - Glendale
- - Tucson
Colorado
- - Arvada
- - Westminster
Georgia
- - Augusta
- - Macon
Idaho
- - Meridian
Illinois
- - Evergreen Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2013-07-23 |
| Est. Completion | 2014-09-03 |
| Phase | Phase 2 |
What the finished NCT01906489 record still lists
NCT01906489 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 3,205-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01906489 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01906489 about?
NCT01906489 is a clinical study titled "20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia". 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.
What is the current status of trial NCT01906489?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2013-07-23. Estimated completion is 2014-09-03.
What conditions does trial NCT01906489 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Anemia.
What interventions are being tested in trial NCT01906489?
The interventions under investigation include: Placebo (DRUG), AKB-6548 (DRUG).
Who is sponsoring clinical trial NCT01906489?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01906489 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01906489's enrollment target sits among peer trials
210 38th of 101 higher than 64 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
RECRUITING · Phase 2
-
A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
RECRUITING · Phase 2
-
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
RECRUITING · Phase 2
-
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
ACTIVE NOT RECRUITING · Phase 2
-
Metformin in Kidney Disease
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02665923 · 210 participants
Gastric Emptying in Neonates and Infants After Formula Feeding
- NCT03322891 · 210 participants · NA
Improving Health Literacy in African-American Prostate Cancer Patients
- NCT03544489 · 210 participants · Phase 2
Effectiveness of Exercise After an ICD
- NCT04408430 · 210 participants · NA
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI