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The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.
Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitriol | Experimental | General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks. |
|
| Control | No Intervention | General treatments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol | Drug | Calcitriol 0.5 ug/BIW for 24 weeks. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| the percentage change of proteinuia | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients achieving at least a 15% decrease in proteinuria | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| mean change of renal function (serum creatine, cystatin C, eGFR) | 24 weeks | |
| blood pressure | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Chen, M.D. PhD | Contact | 86-21-52889387 | chenjing1998@fudan.edu.cn | |
| Li You, M.D. PhD | Contact | 86-21-52888133 | youlizzy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, M.D. PhD | Division of Nephrology, Huashan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| 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 |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |