Use of QRX3 for Acute Tubular Necrosis Type of Renal Failure in Hospitalized Patients ( QRX-3 in ARF)

NCT07161843 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 0002
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Use of QRX-3 in hospitalized patients with pediatric and adult patients with acute tubular necrosis renal failure

Conditions

Acute Renal Failure (ARF); Acute Tubular Necrosis

Keywords

acute renal failure; acute tubular necrosis

Outcome Measures

Primary Outcomes (1)

• Rate of change in creatinine glomerular filtration rate

  compare the outcome effect of added QRX-3 drug to placebo in addition to standard therapy on the rate of change from baseline of creatinine GFR in ATN patients

  28 days

Secondary Outcomes (2)

• daily change in glomerular filtration rate in ml/min

  7 days

• daily change in cystatin C level in mg/dl

  7 days

Other Outcomes (1)

• effect of QRX-3 on recovery of renal function in patients with ATN renal failure

  28

Study Arms (2)

Use of QRX-3 in addition to standard therapy

EXPERIMENTAL

QRX-3 drug orally as twice daily in addition to standard conventional therapy will be given to this group for 28 days

Drug: QRX-3

control group

PLACEBO COMPARATOR

placebo twice daily will be given to this group in addition to standard therapy

Drug: QRX-3

Interventions

QRX-3 DRUG

Combination of QRX-3 with standard therapy will be given to one arm in trial , another arm will receive placebo

Also known as: Eseronate

Use of QRX-3 in addition to standard therapy; control group

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients
• presence of Acute renal failure
• Nephrologist diagnosis of Acute tubular necrosis or fractional excretion of sodium of \>2%
• willingness to participate

You may not qualify if:

• High risk of bleeding Absence of hydronephrosis or obstructive uropathy Absence of baseline dialysis use single kidney status

Sponsors & Collaborators

• Ebima Clifford Okundaye: lead

Study Sites (1)

Neukidney Inc

Rosharon, Texas, 77583, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Cortex Necrosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Ebima Okundaye, MD

CONTACT

9738855457; cliffordebima@gmail.com

Study Design

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

Model Details: added QRX-3 to standard regime

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: September 9, 2025
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)