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Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Primary Purpose

Chronic Kidney Disease, Proteinuria

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Calcitriol

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring mild proteinuria, calcitriol, renal function, blood pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Huashan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Calcitriol

Control

Arm Description

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

General treatments.

Outcomes

Primary Outcome Measures

the percentage change of proteinuia

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01820832

First Posted

March 19, 2013

Last Updated

March 28, 2013

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01820832

Brief Title

Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Proteinuria

Keywords

mild proteinuria, calcitriol, renal function, blood pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Calcitriol

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

General treatments.

Intervention Type

Drug

Intervention Name(s)

Calcitriol

Other Intervention Name(s)

1, 25 - dihydroxy Cholecalciferol

Intervention Description

Calcitriol 0.5 ug/BIW for 24 weeks.

Primary Outcome Measure Information:

Title

the percentage change of proteinuia

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

24 weeks

Other Pre-specified Outcome Measures:

Title

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

Time Frame

24 weeks

Title

blood pressure

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Chen, M.D. PhD

Phone

86-21-52889387

chenjing1998@fudan.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Li You, M.D. PhD

Phone

86-21-52888133

youlizzy@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Chen, M.D. PhD

Organizational Affiliation

Division of Nephrology, Huashan Hospital, Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huashan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li You, M.D. PhD

Phone

86-21-52888133

youlizzy@gmail.com

12. IPD Sharing Statement

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Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

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