Hyperphosphatemia in ESRD-HD patients
Conditions
Interventions
Experimental group:oral
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 77 Years
Inclusion criteria
Inclusion criteria: 1. Patients who could understand and follow the protocol, voluntarily participate in this trial, and sign a written informed consent form; 2. Male or female aged 18 - 80 (inclusive) years; (1) Females who were non-pregnant, non-lactating, and met one of the following conditions: 1) Post-menopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal therapy; 2) With documented history of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (excluding tubal ligation); 3) Females must agree to practice contraception; therefore, females must be infertile or agree to adopt an acceptable contraception measures from randomization through 45 days after the end of the study, including intrauterine device (IUD) with spermicide, female condom with spermicide, contraceptive sponge with spermicide, intravaginal contraceptive system (e.g., NuvaRing), diaphragm with spermicide, cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives, abstinence, or with an infertile partner; (2) Men must agree to practice contraception (or to avoid sperm donation); therefore, males must be infertile or agree to adopt one of the following approved contraception measured from randomization through 45 days after the end of the study: male condom with spermicide, with an infertile partner, or with a female partner using IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, intravaginal contraceptive system (e.g., NuvaRing), diaphragm with spermicide, cervical cap with spermicide, or oral, implantable, transdermal or injectable contraceptives; 3. Patients undergoing maintenance hemodialysis (for at least 3 months), 3 times a week, of whom the dialysis regimen remained unchanged during the trial; 4. Patients with stable vascular access as evaluated by the investigator; 5. Patients with measured Kt/V value >= 1.2 within 3 months prior to screening; 6. Patients who had received treatment of phosphate binders for at least 3 weeks at screening (the dose of phosphate binders was stable within the last 3 weeks), with serum phosphate level of 4.0 - 7.0 mg/dL (1.29 - 2.26 mmol/L) and serum calcium > 8.40 mg/dL (2.1 mmol/L) at screening; 7. Patients with serum phosphorus level within 9.0 - 10.0 mg/dL (2.91 - 3.23 mmol/L) after washout for 1 week or 6.0 - 10.0 mg/dL (1.94 - 3.23 mmol/L) after washout for 2 to 3 weeks, and serum phosphorus level increased by at least 1.5 mg/dL (0.48 mmol/L) after washout compared with that at screening; 8. If patients were receiving treatment of any vitamin D or calcimimetics regimen, the dose remained unchanged within 4 weeks prior to the screening period and throughout the study; 9. Patients who were accessible to communication tools such as telephone every day.
Exclusion criteria
Exclusion criteria: 1. Patients with measured serum calcium (corrected value) 11.0 mg/dL (2.75 mmol/L) after washout period; 2. Patients with the last serum iPTH > 1200 pg/mL according to the medical record; 3. Patients with persistent metabolic acidosis with 2 consecutive measured serum carbon dioxide binding capacity (or bicarbonate) = 6 and the number of bowel movements >= 3 for at least 2 days; 8. Patients with any evidence of malignancy or receiving treatment for malignancy within 1 year, excluding non-melanoma of the skin; 9. Patients with hepatitis B surface antigen (HBsAg) positive, hepatitis C virus (HCV) antibody positive, syphilis and human immunodeficiency virus (HIV) antibody positive at screening; 10. Patients with hepatic impairment (hepatic insufficiency or serum total bilirubin, aspartate aminotransferase, or alanine aminotransferase >= 2 x upper limit of normal (ULN]) or concurrent liver cirrhosis; 11. Patients with any active infection requiring systemic therapy within 3 weeks prior to the first dose; 12. Patients with history of alcoholism, illicit drugs, major psychiatric disorders, or any drug abuse or addiction within 1 year prior to screening; 13. Patients with an expected survival < 6 months; 14. Patients who had participated in any clinical trial or used any investigational drug within 1 month prior to screening; 15. Patients who were judged by the investigator as inappropriate for this study (e.g., unable to get in touch).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compared with the placebo group, the difference of serum phosphorus change from baseline in the Tenapanor group at the end-of-4-week-treatment visit or at the early discontinuation visit.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of serum phosphorus level from baseline in the Tenapanor group at the end-of-4-week-treatment visit or at the early discontinuation visit;The number of patients in the Tenapanor group achieving the target serum phosphorus level (defined as < 5.5 mg/dL [1.78 mmol/L]) during the 4-week treatment period compared with the placebo group;Compared with the placebo group, the change of intact parathyroid hormone (iPTH) from baseline in the Tenapanor group at the end-of-4-week-treatment visit or at the early discontinuation visit;The safety of Tenapanor Tablets evaluated by adverse event records, stool form and frequency of bowel movements, vital signs, 12-lead electrocardiography (ECG), pre-dialysis weight, physical examination, and clinical laboratory test.; | — |
Countries
China
Contacts
Public ContactLi Zuo
Peking University People's Hospital
Outcome results
None listed