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A Study of Autologous Neo-Kidney Augment™ (NKA) in Patients With Diabetic Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03270956
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
inRegen

Brief Summary:
Therapeutic intervention with NKA is intended to delay the need for renal replacement therapy (dialysis or transplant) which, based on the current standard of care, is inevitable for patients with end stage CKD. The purpose of the present study is to assess the safety and efficacy of up to 2 injections of NKA given 6 months (+4 weeks) apart (maximum).

Condition or disease Intervention/treatment Phase
Diabetic Chronic Kidney Disease Biological: Neo-Kidney Augment™ (NKA) Phase 2

Detailed Description:

NKA is made from expanded autologous selected renal cells obtained from each individual subject's kidney biopsy.

All subjects enrolled will receive NKA. Subjects will receive their first NKA injection as soon as the NKA product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

The rate of progression of renal insufficiency (assessed via serial measurements of eGFR through 24 months after the last NKA injection) will be compared against the individual subject's rate of eGFR decline through 24 months following the final NKA treatment. The rate of progression of renal insufficiency from subjects (if any) who received a single NKA injection may be compared against that from subjects who received two NKA injections.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Safety and Tolerability Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Neo-Kidney Augment
Neo-Kidney Augment (NKA) Treatment - Patients will receive their first treatment of 2 injections of NKA as soon as NKA product is made available.
Biological: Neo-Kidney Augment™ (NKA)
Neo-Kidney Augment (NKA) Autologous selected renal cells (SRC).




Primary Outcome Measures :
  1. Procedure and/or product related adverse events [ Time Frame: Through 24 months following last NKA injection ]
    Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term


Secondary Outcome Measures :
  1. Renal specific adverse events [ Time Frame: Through 24 months following last NKA injection ]
    Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term


Other Outcome Measures:
  1. Renal function [ Time Frame: Through 24 months following last NKA injection ]
    Change in Renal Function as assessed by eGFR

  2. Renal function [ Time Frame: Through 24 months following last NKA injection ]
    Change in Renal Function as assessed by serum creatinine

  3. Renal function [ Time Frame: Through 24 months following last NKA injection ]
    Change in Renal Function as assessed by proteinuria



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is male or female, 30 to 65 years of age on the date of informed consent.
  2. The subject has an established diagnosis of T2DM.
  3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
  4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m2 inclusive at the Screening Visit and prior to NKA injection.
  5. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to NKA injection(s). Note BP should not be significantly below the previously recorded stable pressure.
  6. The subject has stable blood pressure or has ongoing and stable treatment with an angiotensin-converting-enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB) initiated at least 8 weeks prior to renal biopsy. Treatment must be stable during the 6 week period immediately prior to NKA injection. Stable treatment is defined as dose adjustment no less than one half of the current dosage and no more than 2 times the current dosage. Dose interruptions up to 7 days due to medical necessity are allowed.
  7. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.
  8. The subject is willing and able to refrain from NSAID consumption (including aspirin) as well as clopidogrel, prasugrel, or other platelet inhibitors during the period beginning 7 days before through 7 days after both the renal biopsy and NKA injection(s).
  9. The subject is willing and able to refrain from consumption of fish oil and platelet aggregation inhibitors, such as dipryridamole (ie, Persantine®), during the period beginning 7 days before through 7 days after both the renal biopsy and NKA injection(s).
  10. The subject is willing and able to cooperate with all aspects of the protocol.
  11. The subject is willing and able to provide signed informed consent.

Exclusion Criteria:

  1. The subject has a history of type 1 diabetes mellitus.
  2. The subject has a history of renal transplantation.
  3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.
  4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
  5. The subject has hemoglobin levels less than 9 g/dL prior to each NKA injection.
  6. The subject has abnormal coagulation status as measured by activated partial thromboplastin time (APTT), prothrombin time international normalized ratio (PT INR), and/or platelet count at the Screening Visit.
  7. The subject has a bleeding disorder(s) or is taking anticoagulants, such as Coumadin® (warfarin) or direct thrombin inhibitors that, in the judgment of the Investigator, would interfere with the performance of study procedures.
  8. The subject has small kidneys (average size less than 9 cm) or has only one kidney, as assessed by ultrasound and/or MRI prior to renal biopsy, unless earlier radiology reports (generated within 1 year of the Screening Visit) are made available to confirm kidney size and number.
  9. The subject has a known allergy or contraindication(s), or has experienced severe systemic reaction(s) to kanamycin or structurally similar aminoglycoside antibiotic(s)
  10. The subject has a history of anaphylactic or severe systemic reaction(s) or contraindication(s) to human blood products or materials of animal origin (eg, bovine, porcine).
  11. The subject is not a good candidate to undergo percutaneous NKA injection, in the judgment of the surgeon or physician who will perform the procedure. This includes individuals who are morbidly obese (defined as BMI greater than 45 kg/m2), have excessive fat surrounding the kidney, or who are otherwise at excessive risk for serious complications.
  12. The subject has a history of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
  13. The subject has a clinically significant infection requiring parenteral antibiotics within 6 weeks of NKA injection.
  14. The subject has acute kidney injury or has experienced a rapid decline in renal function during the last 3 months prior to NKA injection.
  15. The subject has any of the following conditions prior to NKA injection: renal tumors, polycystic kidney disease, anatomic abnormalities that would interfere with the NKA injection procedure or evidence of a urinary tract infection.
  16. The subject has incapacitating cardiac and/or pulmonary disorders.
  17. The subject has a history of cancer within the past 3 years (excluding non-melanoma skin cancer and carcinoma in situ of the cervix).
  18. The subject has clinically significant hepatic disease (ALT or AST greater than 3 times the upper limit of normal) as assessed at the Screening Visit.
  19. The subject is positive for active infection with Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), and/or Human Immunodeficiency Virus (HIV) as assessed at the Screening Visit.
  20. The subject has a history of active tuberculosis (TB) requiring treatment within the past 3 years.
  21. The subject is immunocompromised or is receiving immunosuppressive agents, including individuals treated for chronic glomerulonephritis within 3 months of NKA injection. Note: inhaled corticosteroids and chronic low-dose corticosteroids (less than or equal to 7.5 mg per day) are permitted as are brief pulsed corticosteroids for intermittent symptoms (eg, asthma).
  22. The subject has a life expectancy less than 2 years.
  23. The female subject is pregnant, lactating (breast feeding), or planning a pregnancy during the course of the study. Or, the female subject is of child-bearing potential and is not using a highly effective method(s) of birth control, including sexual abstinence. Or, the female subject is unwilling to continue using a highly-effective method of birth control throughout the duration of the study. Note: A highly effective method of birth control is defined as one that results in a low failure rate (ie, less than one percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices IUDs, sexual abstinence, or a vasectomized partner.
  24. The subject has a history of active alcohol and/or drug abuse that, in the judgment of the Investigator, would impair the subject's ability to comply with the protocol.
  25. The subject's health status would, in the judgment of the Investigator, be jeopardized by participating in the study.
  26. The subject has used an investigational product within 3 months prior to NKA injection without receiving written consent from the Medical Monitor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270956


Contacts
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Contact: Jaclyn Guillory (513) 598-9290 jguillory@ctifacts.com
Contact: William Aronstein, PhD MD (513) 598-9290 baronstein@ctifacts.com

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
United States, Idaho
Boise Kidney & Hypertension Institute Not yet recruiting
Boise, Idaho, United States, 83642
Contact: Aronald Silva, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, North Carolina
University of North Carolina- Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
inRegen

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Responsible Party: inRegen
ClinicalTrials.gov Identifier: NCT03270956     History of Changes
Other Study ID Numbers: REGEN-003
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency