Role of QRX-3 in Chronic Kidney Disease Patients in Outpatients Clinics

NCT ID: NCT06948292

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-10-30

Brief Summary

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QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD ( nicotinamide adenine dineuclotide )within the kidney cells; leading to decrease oxidative changes intracellularly, repair of renal tubular injury and restoration of optimized renal function above baseline , will be studied in patients with progressive chronic kidney disease over 12 months . The result of the change in renal function expressed as creatinine GFR (Glomerular filtration decline) over the treatment duration will be compared in the treatment group will be compared to control group without the medication during that same period .

Detailed Description

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Conditions

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Chronic Kidney Disease Stages 3-5 Diabetic Kidney Disease Hypertensive Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

QRX-3 added to intervention group in addition to standard therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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control group

control group - continued on standard therapy for CKD

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

QRX-3 drug given in addition to standard therapy for CKD

Group Type ACTIVE_COMPARATOR

QRX-3

Intervention Type DRUG

phase 2B CKD study

Interventions

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QRX-3

phase 2B CKD study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with Chronic kidney disease stage 3-5
* Estimated Glomerular function by MDRD of less than 60mls/min
* Patients with declining renal function ( as measured by eGFR by MDRD )
* Rate of decline of eGFR over the last one year of less than 20%
* Negative Serology markers for CKD etiology
* Provider perceived adherence to study follow- up

Exclusion Criteria

* Rapid rate of decline in kidney function of \> 10 % over 3 months
* Symptomatic renal failure
* Presence of any suspected Acute renal failure superimposed
* Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI
* No known reversible cause of renal decline
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ebima Clifford Okundaye

INDUSTRY

Sponsor Role lead

Responsible Party

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Ebima Clifford Okundaye

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Neukidney Inc

Pasedena, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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0002B

Identifier Type: -

Identifier Source: org_study_id

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