MedDataX Logo

Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

NCT ID: NCT01820832

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Proteinuria

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

mild proteinuria calcitriol renal function blood pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Calcitriol

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

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Calcitriol 0.5 ug/BIW for 24 weeks.

Control

General treatments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calcitriol

Calcitriol 0.5 ug/BIW for 24 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

1, 25 - dihydroxy Cholecalciferol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jing Chen

Professor, PhD., MD, Renal Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jing Chen, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Huashan Hospital, Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jing Chen, M.D. PhD

Role: CONTACT

Phone: 86-21-52889387

Email: [email protected]

Li You, M.D. PhD

Role: CONTACT

Phone: 86-21-52888133

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Li You, M.D. PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Calcitriol-MP-1

Identifier Type: -

Identifier Source: org_study_id