| Trial ID: | L0943 |
| Source ID: | NCT04456803
|
| Associated Drug: |
Ferric Citrate Tablet
|
| Title: |
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperphosphatemia|End Stage Renal Disease|ESRD
|
| Interventions: |
DRUG: Ferric citrate tablet|DRUG: Sevelamer carbonate tablet
|
| Outcome Measures: |
Primary: 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 | Secondary: 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), 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
|
| Sponsor/Collaborators: |
Sponsor: Sinomune Pharmaceutical Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
239
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-05-24
|
| Completion Date: |
2022-09-13
|
| Results First Posted: |
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| Last Update Posted: |
2024-04-17
|
| Locations: |
The first affiliated hospital of Baotou medical college, Baotou, China|Beijing Tongren Hospital, 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|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|The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, China
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| URL: |
https://clinicaltrials.gov/show/NCT04456803
|
