NCT00862693

Brief Summary

Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the treatment of IgA nephropathy, which has no specific treatment at present.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 17, 2011

Status Verified

March 1, 2009

Enrollment Period

1.4 years

First QC Date

March 16, 2009

Last Update Submit

February 16, 2011

Conditions

GlomerulonephritisAutoimmune Diseases

Keywords

Immunoglobulin AAntibodiestreatment

Outcome Measures

Primary Outcomes (1)

  • decline of urine protein

    analysis urine protein after 12 months treatment

    12 months treatment

Study Arms (2)

1 calcitriol

EXPERIMENTAL

calcitriol 0.5ug/BIW for 12 months

Drug: Calcitriol

2

NO INTERVENTION

no intervention

Interventions

CalcitriolDRUG

0.5ug/Biw

1 calcitriol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-65 years
  • Biopsy-confirmed IgA nephropathy
  • Proteinuria \> 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or estimated glomerular filtration rate \< 60 ml/min/1.73m2
  • Corrected serum calcium level \< or = 2.45 mmol/l
  • 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
  • Participation in any previous trial on paricalcitol
  • Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
  • Patients receiving treatment of corticosteroid
  • 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 paricalcitol or other vitamin D analogs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Division, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (1)

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PMID: 38299639DERIVED

MeSH Terms

Conditions

GlomerulonephritisAutoimmune Diseases

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

Hong Zhang, Prof

CONTACT

+86-10-66551122-2288hongzh@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Study Completion

March 1, 2011

Last Updated

February 17, 2011

Record last verified: 2009-03

Locations

CN(1)