Use of New Drug QRX-3 for Prevention and Treatment of Chronic Kidney Disease Progression

NCT06866236 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 0001
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease CKD is estimated to affect nearly over 800 million people globally today (with roughly 125,000 people ending up annually on dialysis in the United States alone. CKD is a contributor to illness and is associated with a diminished quality of life and reduced life expectancy . In this study the investigators are using a novel drug to target improved function of the kidneys.

Conditions

Chronic Kidney Diseases; Acute Kidney Injury; Kidney Failure

Keywords

CKD, CKD treatment , renal function

Outcome Measures

Primary Outcomes (1)

• change in Glomerular filtration rate

  change percentage in kidney function level measured with cystatin creatinine glomerular filtration rate

  1 year

Secondary Outcomes (2)

• change in Proteinuria

  1 year

• change in rate of Glomerular filtration rate decline

  1 year

Study Arms (2)

intervention

ACTIVE COMPARATOR

QRX-3 - two capsules orally twice daily

Drug: QRX-3

placebo

PLACEBO COMPARATOR

placebo pill - one capsule orally twice daily

Drug: QRX-3

Interventions

QRX-3 DRUG

capsule

intervention; placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with Chronic kidney disease
• 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 \> 20 % over last one year
• 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

Renal Insufficiency, Chronic; Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: placebo arm with intervention pill arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Model Details: Randomized placebo double control

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)