NCT01773382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

January 4, 2013

Last Update Submit

January 18, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1

    6 months

Study Arms (2)

control

NO INTERVENTION

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

weight reduction

EXPERIMENTAL

target weight reduction is 3-5% from baseline

Behavioral: weight reduction

Interventions

1. Set target daily energy requirement by nutritionist (25-30 Kcal/Kg/day minus 500 Kcal) 2. Advice and encourage patients to do aerobic exercise at least 30 minutes/day for 4-5 days/weeks. 3. Daily body weight measurement. 4. Record food diary

Also known as: controlled weight reduction program
weight reduction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Chulalongkorn university

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Related Publications (2)

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  • 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.

MeSH Terms

Conditions

Proteinuria

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Piyawan Kittiskulnam, M.D.

    Chulalongkorn University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kidney and metabolic research center, Faculty of medicine

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 23, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations