CKD 5D, Hemodialysis, Hyperphosphatemia Undergoing Hemodialysis
Conditions
Brief summary
The efficacy and safety of tenapanor plus PBs in Chinese patients are still unclear. Therefore, we aim to conduct a real-world study to explore the effect of combining two drugs with different mechanisms on hyperphosphatemia management.This real-world study will enroll hemodialysis patients with hyperphosphatemia who are on PBs therapy.
Interventions
None listed
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. The subject has provided written informed consent prior to the initiation of any study-related activities. 2. Male or female subjects aged ≥18 years at the time of signing the informed consent form. 3. The subject is receiving regular maintenance hemodialysis (3 times per week, 4 hours per session) for at least 3 months. 4. The patient has been on phosphate binder therapy for at least 3 weeks, with a stable dose. 5. Serum phosphorus \> 4.5 mg/dL.
Exclusion criteria
1. Hypersensitivity to Tenapanor or any excipients of the formulation. 2. History of diarrhea within 1 week prior to the start of treatment. Diarrhea is defined as a Bristol Stool Form Scale (BSFS) score ≥6 (i.e., mushy or liquid stools with no solid pieces), a daily bowel movement frequency ≥3 times, and a duration of ≥2 days. 3. Life expectancy \< 6 months. 4. Expected or planned kidney transplantation during the study period. 5. History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D). 6. Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with serum phosphorus levels <5.5 mg/dL | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with serum phosphorus levels <5.5 mg/dL | 1、2、6 months |
| The proportion of patients achieving the target serum phosphorus level (<4.5 mg/dL) | 1、2、3、6 months |
| The change from baseline in serum phosphorus levels | 1、2、3、6 months |
| The dosage and quantity of Tenapanor and phosphate binders used by patients | 1、2、3、6 months |
| The change from baseline in intact parathyroid hormone (iPTH) levels | 1、2、3、6 months |
Countries
China
Contacts
CONTACTLi Zuo
Outcome results
None listed