Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vadadustat.
- Who it may be relevant to
- Registry conditions: Renal Anemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Interventional Study Evaluating the Effects of Vadadustat on Anemia, Quality of Life, and Inflammatory Response in Dialysis Patients and Exploring Predictors of Treatment Response
Overview
This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. The study compares add-on vadadustat plus background darbepoetin alfa with background darbepoetin alfa alone, with each treatment period lasting 8 weeks and separated by a 4-week washout period. Monthly laboratory assessments and dialysis adequacy measurements will be performed to evaluate anemia control, quality of life, inflammation, and dialysis adequacy.
Interventions
- Drug Vadadustat
Vadadustat administered orally for 8 weeks during the assigned treatment period. In this two-period crossover study, the two treatment periods are separated by a 4-week washout period.
Primary outcome measures
- Change in Hemoglobin [Time frame: Baseline and end of each 8-week treatment period (up to 5 months).]
Secondary outcome measures (9)
- Change in SF-36 Physical Component Summary score [Time frame: Baseline and end of each 8-week treatment period (up to 5 months).]
- Change in SF-36 Mental Component Summary score [Time frame: Baseline and end of each 8-week treatment period (up to 5 months).]
- Change in C-reactive protein [Time frame: Baseline and monthly during the study period, up to 5 months.]
- Change in erythrocyte sedimentation rate [Time frame: Baseline and monthly during the study period, up to 5 months.]
- Change in interleukin-6 [Time frame: Baseline and monthly during the study period, up to 5 months.]
- Change in serum iron [Time frame: Baseline and monthly during the study period, up to 5 months.]
- Change in total iron-binding capacity [Time frame: Baseline and monthly during the study period, up to 5 months.]
- Change in ferritin [Time frame: Baseline and monthly during the study period, up to 5 months.]
- Change in transferrin saturation [Time frame: Baseline and monthly during the study period, up to 5 months.]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- Receiving maintenance peritoneal dialysis
- Followed at the outpatient clinics of MacKay Memorial Hospital
- Receiving background darbepoetin alfa therapy
- Able and willing to provide informed consent
Exclusion criteria
- Blood pressure >170/80 mmHg on three separate occasions
- Recent cardiovascular events within the past 3 months, including coronary artery disease, myocardial ischemia, cerebrovascular disease, or peripheral artery disease
- Gastrointestinal bleeding within the past 3 months
- Active malignancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07537816 · 24MMHIS374e