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

NCT06948292 | Completed Phase 2 FDA Drug

• 1 other identifier: 0002B
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

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

Keywords

CKD; estimated GFR (eGFR); proteinuria; random urine protein creatinine ratio; creatinine change

Outcome Measures

Primary Outcomes (1)

• daily change in glomerular filtration rate by creatinine in mls/min

  mean change in glomerular filtration rate by creatinine in mls/min in one year compare to baseline at screening

  12 months

Secondary Outcomes (1)

• change in proteinuria by mg/g

  12 months

Study Arms (2)

control group

NO INTERVENTION

control group - continued on standard therapy for CKD

Intervention group

ACTIVE COMPARATOR

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

Drug: QRX-3

Interventions

QRX-3 DRUG

phase 2B CKD study

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ebima Clifford Okundaye: lead

Study Sites (1)

Neukidney Inc

Pasedena, Texas, 77504, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Hypertensive Nephropathy; Proteinuria

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: QRX-3 added to intervention group in addition to standard therapy

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: March 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 4/21/2025 to 10/21/2025

Locations

US (1)