Hyperphosphatemia
Conditions
Brief summary
A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Detailed description
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Interventions
tablets for oral administration.
DRUGSevelamer carbonate
tablets for oral administration.
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand the procedures of this trial and provide written informed consent voluntarily; 2. Age ≥ 18 years, male or female; 3. On a stable hemodialysis regimen at a frequency of two or three times per week for at least 12 weeks prior to the screening visit; 4. Serum phosphorus within the trial-required range.
Exclusion criteria
1. Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome; 2. Pregnant or breastfeeding; 3. Any history of a parathyroid intervention; 4. Diarrhea or loose stools occurred within 1 week prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis | 4 weeks | The change in serum phosphorus (sP) level from baseline to the end of treatment |
Countries
China
Contacts
Primary ContactJing Xu
Backup ContactWei Chen
Outcome results
None listed