A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
Study Details
Study Description
Brief Summary
A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance hemodialysis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
The main body of this study has 5 intervention arms, 4 VS-505 treatment arms of various dosage plus 1 active control arm of Sevelamer Carbonate, each consists 25 subjects. Prior to this main part, a dose escalating cohort of 25 subjects is added to evaluate the tolerability of VS-505 in Chinese patient population.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: VS-505 500mg VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg. |
Drug: VS-505
4 dosages of experimental drug
|
Experimental: VS-505 750mg VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg. |
Drug: VS-505
4 dosages of experimental drug
|
Experimental: VS-505 1500mg VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg. |
Drug: VS-505
4 dosages of experimental drug
|
Experimental: VS-505 2250mg VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg. |
Drug: VS-505
4 dosages of experimental drug
|
Active Comparator: Sevelamer Carbonate 1600mg Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg. |
Drug: Sevelamer Carbonate
Active Comparator
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Serum phosphorus change from baseline to end of treatment [6 weeks]
Secondary Outcome Measures
- Time to serum phosphorus response,defined as serum phosphorus level decrease by 0.32 mmol/L(1 mg/dL)and serum phosphorus level below 1.78 mmol/L(5.5 mg/dL) [6 weeks]
- The achievement rate of subjects with serum phosphorus in the target range 1.13-1.78 mmol/L(3.5-5.5 mg/dL)by the end of treatment [6 weeks]
- Serum calcium change from baseline to end of treatment [6 weeks]
- Serum Ca×P change from baseline to end of treatment [6 weeks]
- Serum iPTH change from baseline to end of treatment [6 weeks]
Other Outcome Measures
- Serum ferritin change from baseline to end of treatment [6 weeks]
- Number of serious adverse events (SAEs) [6 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy;
-
Serum phosphorus level range from >1.94 mmol/L (6.0 mg/dL) to ≤3.23 mmol/L (10.0 mg/dL) at the end of washout phase.
Exclusion Criteria:
-
Kidney transplant patient or scheduled kidney transplant, or change to peritoneal dialysis, home hemodialysis or plan to relocate to another dialysis center during the study period;
-
Serum phosphorus level is <1.29 mmol/L(4.0 mg/dL) or >2.42 mmol/L(7.5 mg/dL) at screening, or documented to be >3.23 mmol/L(10 mg/dL) within the latest three month prior to screening (screening included);
-
Serum calcium level is <8 mg/dL or >11 mg/dL at the screening;
-
Serum immunoreactive parathyroid hormone (iPTH)>1000 pg/mL at the screening;
-
History of hemochromatosis or serum ferritin value ≥1000 μg/L at screening;
-
Current clinically significant gastrointestinal (GI) disorder, or history of intestine obstruction, gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening;
-
Poorly controlled hypertension, cardiovascular disorders, and history of cerebrovascular disease or cardiovascular disease event within 24 weeks (6 months) prior to screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Peking University People's Hospital | Beijing | Beijing | China | |
2 | Peking University Third Hospital | Beijing | Beijing | China | |
3 | Zhongshan Hospital Xiamen University | Xiamen | Fujian | China | |
4 | Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China | |
5 | The Third Hospital of Hebei Medical University | Shijia Zhuang | Hebei | China | |
6 | The Second Affiliated Hospital of Xingtai Medical College | Xingtai | Hebei | China | |
7 | Renmin Hospital of Wuhan University | Wuhan | Hubei | China | |
8 | The Second People's Hospital of Changzhou | Changzhou | Jiangsu | China | |
9 | The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | |
10 | Affiliated Hospital of Nantong University | Nantong | Jiangsu | China | |
11 | Wuxi People's Hospital | Wuxi | Jiangsu | China | |
12 | Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | China | |
13 | Jilin Province People's Hospital | Changchun | Jilin | China | |
14 | The Second Hospital of Jilin University | Changchun | Jilin | China | |
15 | Dalina Municipal Central Hospital | Dalian | Liaoning | China | |
16 | The First Hospital of Dalian Medical University | Dalian | Liaoning | China | |
17 | The Second Hospital of Dalian Medical University | Dalian | Liaoning | China | |
18 | Shanghai General Hospital | Shanghai | Shanghai | China | |
19 | Shanghai Tenth People's Hospital | Shanghai | Shanghai | China | |
20 | Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine | Shanghai | Shanghai | China | |
21 | The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China | |
22 | Tianjin People's Hospital | Tianjin | Tianjin | China | |
23 | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Shanghai Alebund Pharmaceuticals Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APCKD001