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

E

Ebima Clifford Okundaye

Status and phase

Completed
Phase 2

Conditions

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

Treatments

Drug: QRX-3

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD within the kidney cells, is expected to improve baseline renal function when given over a period of one year . The result of the change in renal function will be compared to control without the medication during that same period .

Enrollment

127 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

127 participants in 2 patient groups

control group
No Intervention group
Description:
control group - continued on standard therapy for CKD
Intervention group
Active Comparator group
Description:
QRX-3 in addition to standard therapy for CKD
Treatment:
Drug: QRX-3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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