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

NCT01512862 | Unknown Phase 4 DMC

• 1 other identifier: SNUH-CCTO
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Proteinuria

Keywords

Calcitriol; Off-label

Outcome Measures

Primary Outcomes (1)

• Changes in proteinuria

  Comparison of proteinuria amount checked by random urine protein/creatinine ratio

  6, 12 months after administration

Secondary Outcomes (2)

• Changes in renal function

  3, 6, 9 and 12 months

• Changes in urinary renal damage markers

  6, 12 months

Study Arms (2)

Calcitriol

EXPERIMENTAL

Drug: Calcitriol

Placebo

NO INTERVENTION

Drug: Placebo

Interventions

Calcitriol DRUG

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

Also known as: Calcio® (Hanmi Pharm Co., Korea)

Calcitriol

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

ENROLLING BY INVITATION

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

ENROLLING BY INVITATION

MeSH Terms

Conditions

Proteinuria

Interventions

Calcitriol; Calcium

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Jung Mi Oh, Pharm.D.

  Seoul National Univerisy College of Pharmacy

  STUDY CHAIR

• Yon Su Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayoung Han, M.S.

CONTACT

+82-2-2072-0335; hans1217@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 10, 2012

Record last verified: 2012-04

Locations

KR (3)