The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

NCT01863641 | Unknown Phase 2 DMC

• 2 other identifiers: 1910354604IRCT2013030912762N1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.

Conditions

Systemic Lupus Erythematosus

Keywords

lupus nephritis; proteinuria; SLE; calcitriol

Outcome Measures

Primary Outcomes (1)

• change in proteinuria

  baseline and 12 months

Secondary Outcomes (4)

• risk of lupus flare

  baseline and 12 months

• change in renal function

  baseline and 12 months

• change in serum inflammatory markers

  baseline and 12 months

• change in Systemic Lupus Erythematosus Disease Activity Index score

  baseline and 12 months

Study Arms (2)

treatment group

EXPERIMENTAL

Patients will receive calcitriol at a fixed dose daily.

Drug: calcitriol

control group

ACTIVE COMPARATOR

Patients will receive placebo daily.

Drug: placebo

Interventions

calcitriol DRUG

Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.

treatment group

placebo DRUG

Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.

control group

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years
• Baseline Systemic Lupus Erythematosus Disease Activity Index score \<= 4
• Estimated glomerular filtration rate more than 15 ml/min/1.73m2
• Proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months
• On maintenance dose of prednisolone \< 15 mg/day with or without other immunosuppressive medications
• Serum calcium level in normal range( 8.5-10.5 mg/dl)
• History of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month
• Willingness to give written consent and comply with the study protocol

You may not qualify if:

• Pregnancy, lactating or childbearing potential without effective method of birth control
• Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
• History of malignancy, including leukemia and lymphoma within the past 2 years; Systemic infection requiring therapy at study entry
• Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
• History of drug or alcohol abuse within past 2 years
• Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml)
• Participation in any previous trial on vitamin D analogue
• Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks
• Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D
• On other investigational drugs within last 30 days
• History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
• History of non-compliance; Known history of sensitivity or allergy to vitamin D analogs

Sponsors & Collaborators

• Guilan University of Medical Sciences: lead

Study Sites (1)

Razi hospital

Rasht, Gilan Province, Iran

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis; Proteinuria

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; 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

Study Officials

• Banafsheh ghavidel parsa, MD

  Guilan University of Medical Sciences, Iran

  STUDY CHAIR

• Alireza Amir Maafi, MD Student

  Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alireza Amir Maafi, MD Student

CONTACT

00989376036481; alireza.am427@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Minister of Student Research Committee

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 29, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

IR (1)