Outcome of Use of a Novel Modulator of Oxidative Phosphorylation on Kidney Function in Patients With Progressive Chronic Kidney Disease

NCT07150338 | Completed FDA Drug

• 1 other identifier: 0001A
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Outcome of use of a novel Modulator of Oxidative Phosphorylation on kidney function in patients with Chronic Kidney Disease

Conditions

Chronic Kidney Disease (Stage 3-4); Chronic Kidney Disease (Stages 4 and 5); Proteinuria

Keywords

CKD; CHRONIC KIDNEY; KIDNEY DISEASE; KIDNEY DECLINE; PROGRESSION OF CKD

Outcome Measures

Primary Outcomes (1)

• Decrease rate of GFR decline

  Comparism of percentage and mean change in GFR with time

  6 months

Secondary Outcomes (1)

• Effect on proteinuria with time

  6 months

Study Arms (1)

Patient with progressive chronic kidney disease

GFR decline

Drug: QRX-3; Drug: Eseronate

Interventions

QRX-3 DRUG

Compounded new drug regime

Patient with progressive chronic kidney disease

Eseronate DRUG

Neukidney innovative drug

Also known as: QRX-3

Patient with progressive chronic kidney disease

Eligibility Criteria

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

Study Population

Adult patients with chronic kidney disease stages 3-5

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

• Neukidney Inc.: lead

Study Sites (1)

Premier Kidney clinic

Pasadena, Texas, 77504, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; 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; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• Ebima okundaye, MD

  Neukidney Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: May 20, 2021
• Primary Completion: April 20, 2022
• Study Completion: November 20, 2022
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)