Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients
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ClinicalTrials.gov Identifier: NCT01512862 |
Recruitment Status : Unknown
Verified April 2012 by Yon Su Kim, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : January 19, 2012
Last Update Posted : April 10, 2012
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Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases.
Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Proteinuria | Drug: Calcitriol Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Calcitriol |
Drug: Calcitriol
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
Other Name: Calcio® (Hanmi Pharm Co., Korea) |
No Intervention: Placebo |
Drug: Placebo
Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months |
- Changes in proteinuria [ Time Frame: 6, 12 months after administration ]Comparison of proteinuria amount checked by random urine protein/creatinine ratio
- Changes in renal function [ Time Frame: 3, 6, 9 and 12 months ]Comparison of in serum creatinine level from baseline
- Changes in urinary renal damage markers [ Time Frame: 6, 12 months ]Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline

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Ages Eligible for Study: | 19 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nondiabetic kidney disease patients aged 19-70 years
- MDRD GFR ≥ 30 mL/min/1.73m2
- Patients with residual urine protein/creatinine ratio > 200 mg/g
- Adequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3 months
- Normotensive patients untreated with RAS inhibitors
- Serum intact PTH as 35-500 mg/dL and serum calcium less than 10.2 mg/dL
- Patients who have not been treated vitamin D within the 3 months prior to signing the informed consent form
Exclusion Criteria:
- Patients with nephrotic-range proteinuria (24 hour urine protein >3.5 g/24 hr)
- Patients with rapidly progressive glomerulonephritis
- Patients requiring renal replacement therapy immediately
- Hypercalcemia (uncorrected serum calcium level > 10.2 mg/dL) within 3 months
- Malignant hypertension
- Heart failure (New York Heart Association [NYHA] functional class II to IV or LVEF less than 40%)
- Severe chronic obstructive lung disease
- Decompensated liver disease
- Known allergy or hypersensitivity to vitamin D
- Current treatment with steroids and/or immunosuppressive agents
- No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years
- History of noncompliance to medical regimen
- Inability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512862
Contact: Nayoung Han, M.S. | +82-2-2072-0335 | hans1217@snu.ac.kr |
Korea, Republic of | |
Seoul National University Bundang Hospital | Enrolling by invitation |
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707 | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Yon Su Kim, M.D., Ph.D. 82-2-2072-2264 yonsukim@snu.ac.kr | |
Contact: Dong Ki Kim, M.D., Ph.D. 82-2-2072-2303 dkkim73@gmail.com | |
Principal Investigator: Yon Su Kim, M.D., Ph.D. | |
Sub-Investigator: Dong Ki Kim, M.D., Ph.D. | |
Sub-Investigator: Nayoung Han, M.S. | |
SMG-SNU Boramae Medical Center | Enrolling by invitation |
Seoul, Korea, Republic of, 156-707 |
Study Chair: | Jung Mi Oh, Pharm.D. | Seoul National Univerisy College of Pharmacy | |
Principal Investigator: | Yon Su Kim, M.D., Ph.D. | Seoul National University Hospital |
Responsible Party: | Yon Su Kim, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01512862 |
Other Study ID Numbers: |
SNUH-CCTO |
First Posted: | January 19, 2012 Key Record Dates |
Last Update Posted: | April 10, 2012 |
Last Verified: | April 2012 |
Calcitriol Off-label |
Kidney Diseases Proteinuria Urologic Diseases Urination Disorders Urological Manifestations Calcitriol Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcium Channel Agonists |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents |