A New Application of Amiloride in the Treatment of Patient With Chronic Kidney Disease In Reducing Urinary PROtein

NCT03170336 | Completed Phase 4

• 1 other identifier: GGH2016422H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays, the prevalence of chronic kidney disease (CKD) in China is about 10.8%,and nearly 120 million people suffer from CKD, which has become a serious public health problem in China. Study confirmed that proteinuria is an independent risk factor for the continuous deterioration of glomerular filtration rate (GFR) in patients with CKD. So it is of great significance to explore the strategy of reducing proteinuria. According to our previous study, Amiloride can inhibit the expression of uPAR in podocytes and reduce proteinuria, This clinical trial aims to evaluate the effect and safety of Amiloride in decreasing proteinuria for patients with Chronic Kidney Disease.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• The remission of proteinuria

  after treatment for 12 weeks

Secondary Outcomes (3)

• estimated Glomerular Filtration Rate

  after treatment for 12 weeks

• creatinine

  after treatment for 12 weeks

• hyperkalemia

  at 12 weeks after treatment

Study Arms (2)

amiloride

EXPERIMENTAL

Amiloride first for 8 weeks, then for a washout for 4 weeks, and cross over to receive hydrochlorothiazide for another 8 weeks

Drug: Amiloride

hydrochlorothiazide

ACTIVE COMPARATOR

hydrochlorothiazide first for 8 weeks, then for a washout for 4 weeks, and cross over to receive amiloride for another 8 weeks.

Drug: Hydrochlorothiazide

Interventions

Amiloride DRUG

Amiloride first for 8 weeks, then for a washout for 4 weeks, and cross over to receive hydrochlorothiazide for another 8 weeks.

amiloride

Hydrochlorothiazide DRUG

hydrochlorothiazide first for 8 weeks, then for a washout for 4 weeks, and cross over to receive amiloride for another 8 weeks.

hydrochlorothiazide

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at the age of more than 14 years old with chronic kidney disease
• Good compliance of treatment
• PCR≥500mg/g.cr ，more than double confirmed
• Patients who written informed consent

You may not qualify if:

• less than 14 years of age
• eGFR≤30ml/min.1.73m2；
• poor compliance of treatment
• Previously intolerant or allergic to hydrochlorothiazide
• Patients with history of gout within six months
• Patients with active infection
• Patients with severe cardiopulmonary disease and dysfunction of central nervous system
• history of malignancy
• life expectancy is less than 1 years
• women who are pregnant,lactating and lack of contraception.
• enrolled in other clinical trials within 3 months
• patients who have used immunosuppressive agents or corticosteroids recently or in the past 12 weeks.
• patients without informed consent written or who enable or unwilling to comply with protocol approved by researchers.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Nephrology Dept,Guangdong General Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Amiloride; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients need to be on an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) daily at least four weeks prior to the study. The baseline data would be recorded. Patients enrolled will receive either amiloride or hydrochlorothiazide first for 8 weeks.Then the patients will discontinue amiloride or hydrochlorothiazide for a washout for 4 weeks, but continue with ACEI(angiotensin-converting enzyme inhibitor ) or ARB. After that patients will cross over to receive another medication for another 8 weeks.

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: March 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 18, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)