Suspended

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

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What is being tested

Calcitriol

Drug
Who is being recruted

Urogenital Diseases+13

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 75 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorHuashan Hospital
Study ContactJing Chen, M.D. PhDMore contacts
Last updated: March 29, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01820832
Principal SponsorHuashan Hospital
Study ContactJing Chen, M.D. PhDMore contacts
Last updated: March 29, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesUrological ManifestationsDisease AttributesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesProteinuriaRenal Insufficiency, Chronic

Criteria

12 inclusion criteria required to participate
24 hours urinary calcium excretion level < or = 7.5 mmol
aged 18-75 years
clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis
corrected serum calcium level < or = 2.55 mmol/L
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9 exclusion criteria prevent from participating
history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases
history of malignancy
history of non-compliance
history of sensitivity or allergy to calcitriol or other vitamin D analogs
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

No Intervention
General treatments.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Huashan Hospital, Fudan University

Shanghai, ChinaOpen Huashan Hospital, Fudan University in Google Maps
SuspendedOne Study Center