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Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2012 by Yon Su Kim, Seoul National University Hospital.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01512862

First Posted: January 19, 2012

Last Update Posted: April 10, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Yon Su Kim, Seoul National University Hospital

Purpose

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	Intervention	Phase
Proteinuria	Drug: Calcitriol Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Calcitriol

U.S. FDA Resources

Further study details as provided by Yon Su Kim, Seoul National University Hospital:

Primary Outcome Measures:

Changes in proteinuria [ Time Frame: 6, 12 months after administration ]
Comparison of proteinuria amount checked by random urine protein/creatinine ratio

Secondary Outcome Measures:

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


Estimated Enrollment:	240
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	19 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Nayoung Han, M.S.	+82-2-2072-0335	hans1217@snu.ac.kr

Locations


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

Sponsors and Collaborators

Seoul National University Hospital

Investigators


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

More Information


Responsible Party:	Yon Su Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01512862 History of Changes
Other Study ID Numbers:	SNUH-CCTO
First Submitted:	January 13, 2012
First Posted:	January 19, 2012
Last Update Posted:	April 10, 2012
Last Verified:	April 2012

Keywords provided by Yon Su Kim, Seoul National University Hospital:


Calcitriol Off-label

Additional relevant MeSH terms:


Kidney Diseases Proteinuria Urologic Diseases Urination Disorders Urological Manifestations Signs and Symptoms Calcitriol Calcium Channel Agonists	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

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