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Randomized NKA Injection for DM II and CKD

University of North Carolina at Chapel Hill


Description

To assess the safety and efficacy of up to two NKA injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach; and to assess the impact of NKA injection(s) on renal safety and function.


Keywords:

Diabetes, Kidneys


Category:

Drug or Biologic
Phase:2

Qualifications

 


Age
30 - 80 years


Gender
Any


Study Population

Adults, age 30-80 yrs old with Chronic Kidney disease due to Type 2 Diabetes Mellitus and established diagnosis of diabetic nephropathy as underlying cause of renal disease and NOT yet requiring dialysis.


Investigator

Randal Detwiler
Clinical Professor, Distinguished Professor
Medicine-Nephrology

For questions, contact:

Paula Steele
paulal@med.unc.edu
(919) 843-7829
Visit Website

Recruitment Period End

May 1, 2020

Location

Primary Location
Clinical & Translational Research Center,
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA
Secondary Location
UNC Hospital
101 Manning Dr, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 30 - 80 years

Participant qualification(s) Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) between 20 and 50 mL/min/1.73m2 inclusive. Blood pressure must be controlled and less than 150/90.

Not eligible if: Prior kidney or organ transplant. Currently on dialysis. Uncontrolled diabetes (HgbA1C greater than 10%.).

Number of Visits

    » 30-40 In person visit(s)

    Visits will include Labs, ECGs, MRI, Renal US, Renal Scintigraphy for screening and follow-up. Once screening eligibility, subjects will receive a kidney biopsy. Renal NKA injections will require an overnight stay in UNC Hospitals.

    » 0 Remote visit(s)

Participation Period

36-48 Months

Compensation

visa gift card per visit. Total dependent on treatment arm and visits completed.

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