NCT04805047

Brief Summary

The aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin A nephropathy. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in combination with regular sodium excretion monitoring.

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
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration 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

First Submitted

Initial submission to the registry

March 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

March 17, 2021

Last Update Submit

April 26, 2022

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • 24 hour urine protein excretion

    24 hour urine protein excretion after 3 months

    3 months

Secondary Outcomes (4)

  • 24 hour urine sodium excretion

    3 months

  • blood pressure

    3 months

  • estimated Glomerular Filtration Rate change

    3 months

  • Psychological well-being

    3months

Study Arms (2)

Intervention:education and monitoring

EXPERIMENTAL

regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

Behavioral: education and monitoring

control

NO INTERVENTION

regular care

Interventions

education and monitoringBEHAVIORAL

regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

Intervention:education and monitoring

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male patients\>14 years of age and \<70 years of age
  • Diagnosed immunoglobulin A nephropathy with biopsy;
  • eGFR\>30ml/min per 1.73m2 using Chronic Kidney Disease Epidemiology Collaboration formula
  • Proteinuria \>1 g per day
  • urinary sodium excretion \>200 mmol per day within one month
  • systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg, or a well-controlled blood pressure by treatment with antihypertensives including renin-angiotensin-aldosterone system-blockade (ACE-inhibitor or ARB)
  • Written informed consent

You may not qualify if:

  • Be treated with diuretics
  • Blood pressure \> 180 mmHg systolic or \> 125 mmHg diastolic without medical treatment
  • Have undergone renal transplantation
  • With acute kidney injury (RIFLE criteria) \< 6 months ago
  • Cardiovascular or cerebrovascular event (myocardial infarction, cerebral hemorrhage or infarction) \< 6 months ago
  • With progressive malignancy or pregnancy
  • With contraindications of RAAS blockers
  • unwilling or unable to meet the requirements of the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38299639DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Educational Status

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Huixian Li

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huixian Li

CONTACT

17792905602lihuixian_muye@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 18, 2021

Study Start

May 15, 2021

Primary Completion

May 1, 2023

Study Completion

December 1, 2023

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

CN(1)