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The Effects of Weight Reduction in IgA Nephropathy (WeightPro)

Primary Purpose

Proteinuria

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
weight reduction
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy-proven IgA nephropathy
  • body mass index more than 23 Kg/m2
  • 24 hours urine protein more than 1 g
  • estimated GFR more than 20 ml/min

Exclusion Criteria:

  • pregnancy and lactation
  • rapidly renal function decline
  • crescent formation in renal biopsy more than 10%

Sites / Locations

  • Faculty of medicine, Chulalongkorn universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

weight reduction

Arm Description

standard treatment of IgA nephropathy including ACEI/ARB for blood pressure control (target BP <130/80 mmHg)

target weight reduction is 3-5% from baseline

Outcomes

Primary Outcome Measures

Percentage change of 24-hour proteinuria
The investigators measure amount of 24-hour proteinuria at randomization peroid ( as baseline), first, third and sixth month. Then, investigators calculate the percentage reduction of proteinuria at different time points.

Secondary Outcome Measures

plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1
The investigators measure amount of plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1 at randomization peroid ( as baseline) and sixth month. Then, investigators calculate the percentage reduction of these cytokines in 6 months peroid.

Full Information

First Posted
January 4, 2013
Last Updated
January 18, 2013
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01773382
Brief Title
The Effects of Weight Reduction in IgA Nephropathy
Acronym
WeightPro
Official Title
The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight reduction. The investigators hypothesized that benefits of weight loss may reduce proteinuria.
Detailed Description
This is a prospective randomized study in adult IgA nephropathy. The investigators enrolled 30 patients who have proteinuria exceeds 1 g per day with biopsy proven IgA nephropathy. The experimental arm recieves the non-pharmacological treatment, weight reduction protocol. All patients in this arm must be reduce their body weight in 3-5 % from baseline as protocol. Another arm is control group which recieves standard treatment of IgA nephropathy including ACEIs/ARBs for blood pressure control (target < 130/80 mmHg). The primary outcome is proteinuria level. The secondary outcome is cytokines and inflammatory markers level including interleukin-6, resistin, adiponectin, leptin and monocyte chemoattractant protein-1.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
standard treatment of IgA nephropathy including ACEI/ARB for blood pressure control (target BP <130/80 mmHg)
Arm Title
weight reduction
Arm Type
Experimental
Arm Description
target weight reduction is 3-5% from baseline
Intervention Type
Behavioral
Intervention Name(s)
weight reduction
Other Intervention Name(s)
controlled weight reduction program
Intervention Description
Set target daily energy requirement by nutritionist (25-30 Kcal/Kg/day minus 500 Kcal) Advice and encourage patients to do aerobic exercise at least 30 minutes/day for 4-5 days/weeks. Daily body weight measurement. Record food diary
Primary Outcome Measure Information:
Title
Percentage change of 24-hour proteinuria
Description
The investigators measure amount of 24-hour proteinuria at randomization peroid ( as baseline), first, third and sixth month. Then, investigators calculate the percentage reduction of proteinuria at different time points.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1
Description
The investigators measure amount of plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1 at randomization peroid ( as baseline) and sixth month. Then, investigators calculate the percentage reduction of these cytokines in 6 months peroid.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-proven IgA nephropathy body mass index more than 23 Kg/m2 24 hours urine protein more than 1 g estimated GFR more than 20 ml/min Exclusion Criteria: pregnancy and lactation rapidly renal function decline crescent formation in renal biopsy more than 10%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piyawan Kittiskulnam, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine, Chulalongkorn university
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piyawan Kittiskulnam, M.D.
Phone
6622564251
Ext
101
Email
piyawankitti@gmail.com
First Name & Middle Initial & Last Name & Degree
Piyawan Kittiskulnam, M.D.
First Name & Middle Initial & Last Name & Degree
Talerngsak Kanjanabuch, Ass. Prof.
First Name & Middle Initial & Last Name & Degree
Wiwat Chancharoenthana, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
33782940
Citation
Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.
Results Reference
derived

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The Effects of Weight Reduction in IgA Nephropathy

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