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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
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX003002 once daily | Experimental | JMKX003002 once daily for 4 weeks |
|
| JMKX003002 twice daily | Experimental | JMKX003002 twice daily for 4 weeks |
|
| Sevelamer carbonate | Active Comparator | Sevelamer carbonate three times daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003002 will be administered orally | Drug | tablets for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis | The change in serum phosphorus (sP) level from baseline to the end of treatment | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Xu | Contact | 0086-020-87755766 | xujing2@jemincare.com | |
| Wei Chen | Contact | 0086-020-87755766 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Sevelamer carbonate | Drug | tablets for oral administration. |
|
| The First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |