NCT01820832

Brief Summary

The safety and efficacy of Caltriol on mild proteinuria (\<1.0g/d) reduction in CKD patients.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

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, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

March 19, 2013

Last Update Submit

March 28, 2013

Conditions

Chronic Kidney DiseaseProteinuria

Keywords

mild proteinuriacalcitriolrenal functionblood pressure

Outcome Measures

Primary Outcomes (1)

  • the percentage change of proteinuia

    24 weeks

Secondary Outcomes (1)

  • the proportion of patients achieving at least a 15% decrease in proteinuria

    24 weeks

Other Outcomes (2)

  • mean change of renal function (serum creatine, cystatin C, eGFR)

    24 weeks

  • blood pressure

    24 weeks

Study Arms (2)

Calcitriol

EXPERIMENTAL

General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks.

Drug: Calcitriol

Control

NO INTERVENTION

General treatments.

Interventions

CalcitriolDRUG

Calcitriol 0.5 ug/BIW for 24 weeks.

Also known as: 1, 25 - dihydroxy Cholecalciferol
Calcitriol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-75 years
  • clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis
  • proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month
  • estimated glomerular filtration rate (eGFR)\>60ml/min/1/73m2
  • corticosteroid and immunosuppressive agents withdrawal for at least 6 months
  • normal blood pressure
  • serum intact parathyroid hormone (iPTH) level \>20pg/mL
  • corrected serum calcium level \< or = 2.55 mmol/L
  • serum phosphorus level \< or = 1.68 mmol/L
  • hours urinary calcium excretion level \< or = 7.5 mmol
  • not receive treatment of vitamin D or its analogue within 6 months
  • willigness to give written consent and comply with the study protocol

You may not qualify if:

  • history of sensitivity or allergy to calcitriol or other vitamin D analogs
  • pregnancy, lactating women
  • history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
  • history of malignancy
  • history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases
  • patients receiving drugs contains of calcium
  • patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption
  • participation in any other trials within 1 month
  • history of non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicProteinuria

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Jing Chen, M.D. PhD

    Division of Nephrology, Huashan Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Chen, M.D. PhD

CONTACT

86-21-52889387chenjing1998@fudan.edu.cn

Li You, M.D. PhD

CONTACT

86-21-52888133youlizzy@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD., MD, Renal Division

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 29, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

CN(1)