Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

March 28, 2013 updated by: Jing Chen, Huashan Hospital

Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 24 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcitriol
General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks.
Drug: Calcitriol
Calcitriol 0.5 ug/BIW for 24 weeks.
Other Names:
  • 1, 25 - dihydroxy Cholecalciferol
No Intervention: Control
General treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage change of proteinuia
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
the proportion of patients achieving at least a 15% decrease in proteinuria
Time Frame: 24 weeks
24 weeks

Other Outcome Measures

Outcome Measure
Time Frame
mean change of renal function (serum creatine, cystatin C, eGFR)
Time Frame: 24 weeks
24 weeks
blood pressure
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Jing Chen, M.D. PhD, Division of Nephrology, Huashan Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 28, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Calcitriol-MP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Proteinuria

Clinical Trials on Calcitriol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe