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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20190978 | Other Identifier | http://www.chinadrugtrials.org.cn/ |
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To evaluate the efficacy and safety of ferric citrate tablet in the control of serum phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.
This is a multicenter, randomized, open-label, parallel, phase III study. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). The subjects with regular hemodialysis should stop using the phosphorus binder before the Washout period. During the Treatment period, the subjects will be randomly assigned to the ferric citrate tablets group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric citrate tablet | Experimental | Ferric citrate arm will receive ferric citrate tablets three times a day with each meal. |
|
| Sevelamer carbonate tablet | Active Comparator | Sevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric citrate tablet | Drug | 250mg/tablet, manufactured by Sinomune Pharmaceutical |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in serum phosphorus levels | The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose). | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum phosphorus levels | Changes in serum phosphorus levels from baseline | week 2, 4, 6, 8 |
| Area under the curve of serum phosphorus level | Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Baotou medical college | Baotou | China | ||||
| Beijing Tongren Hospital |
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| Sevelamer carbonate tablet |
| Drug |
800 mg/tablet, manufactured by Genzyme Ireland Limited |
|
|
| week 0, 2, 4, 6, 8, 12 |
| The proportion of subjects whose serum phosphorus levels reached the target | The proportion of subjects whose serum phosphorus levels reached the target range at week 4, 6, 8 and 12 of treatment (the standard was defined as blood phosphorus ≤1.78mmol /L, and ≥1.13mmol /L). | week 4, 6, 8 and 12 |
| The change in serum calcium (corrected) levels. | The change in serum calcium (corrected) levels at week 4, 8 and 12 of treatment as compared to baseline. | week 4, 8 and 12 |
| The change in the level of intact-PTH levels. | The change in the level of intact-PTH levels at week 4, 8 and 12 of treatment as compared to baseline. | week 4, 8 and 12 |
| Beijing |
| China |
| Peking Union Medical College Hospital | Beijing | China |
| The Second Xiangya Hospital of Central South University | Changsha | China |
| Xiangya Hospital Central South University | Changsha | China |
| The second hospital of Dalian medical university | Dalian | China |
| The affiliated hospital of Inner Mongolia Medical University | Hohhot | China |
| The second people's hospital of Huaian | Huai'an | China |
| Jinan central hospital | Jinan | China |
| Shandong province Qianfoshan hospital | Jinan | China |
| Zhongnan Hospital Southeast University | Nanjing | China |
| The people's hospital of Guangxi Zhuang Autonomous Region | Nanning | China |
| Shenzhen people's hospital | Shenzhen | China |
| The third hospital of Hebei medical university | Shijiazhuang | China |
| General Hospital of Tianjin Medical University | Tianjin | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| Henan provincal people's hospital | Zhengzhou | China |
| Zhengzhou People's Hospital | Zhengzhou | China |
| Zhuzhou Central Hospital | Zhuzhou | China |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C025314 | ferric citrate |
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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