Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)

NCT02525263 | Terminated Phase 2 Results DMC

• 1 other identifier: RMCL-CL001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. All enrolled subjects will be treated with up to two injections of NKA at least 6 months apart.

Conditions

Chronic Kidney Disease; Type 2 Diabetes

Keywords

Neo-Kidney Augment; Type 2 Diabetes; Chronic Kidney Disease; Cell Therapy

Outcome Measures

Primary Outcomes (2)

• Procedure and/or Product Related Serious Adverse Events (AE's) Through 12 Months Following the Final NKA Implantation

  Procedure and/or product related adverse events (AE's) through 12 months following the final NKA implantation, as measured by AE reporting.

  12 months following final implantation

• Serial Estimation of Glomerular Filtration Rate (GFR) Through 6 Months Following the Final Cell Implantation, as Measured by Serial Serum Creatinine.

  The patient's serum creatinine was measured using a blood test at predetermined intervals and used to estimate the glomerular filtration rate as an indication of overall renal function.

  6 months following final cell implantation

Secondary Outcomes (1)

• Renal-specific Laboratory Assessments Through 12 Months Following the Last NKA Implantation Under This Protocol.

  12 months following last NKA implantation under this protocol

Other Outcomes (3)

• Laboratory Assessments of Renal Function

  12 months following initial NKA implantation

• Quality of Life as Measured by Serial Kidney Disease Quality of Life Surveys

  Through 18 months after first NKA implantation

• Evaluation of Renal Structure Over Time as Measured by Imaging Modalities.

  12 months following initial NKA implantation

Study Arms (1)

Neo-Kidney Augment

EXPERIMENTAL

NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use.

Biological: Neo-Kidney Augment

Interventions

Neo-Kidney Augment BIOLOGICAL

NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use.

Neo-Kidney Augment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age 30 - 70 years.
• Patients with type 2 diabetes mellitus (T2DM).
• Patients with diabetic nephropathy as the underlying cause of their renal disease.
• If not previously implanted with NKA, CKD defined as a GFR of 20 - 50 mL/min/1.73m2 inclusive. Ifs previously treated with a single NKA implantation, eGFR 15 to 60 mL/min may also enroll.
• Microalbuminuria (urinary albumin-creatinine ratio (UACR) ≥ 30 mg/g or urine albumin excretion ≥ 30 mg/day on 24 hour urine collection) not explained by an alternative diagnosis.
• Systolic blood pressure between 105 and 140 mmHg (inclusive) and diastolic blood pressure ≤90 mmHg.
• Treatment with angiotensin inhibitor (ACEI) or angiotensin blocker (ARB) initiated at least 8 weeks prior to enrollment. Treatment must be stable for the 6 weeks prior to implant. Patients intolerant of ACEI or ARBs may be included if stable BP is within acceptable limits.
• Minimum of 2 measurements of eGFR or serum creatinine (sCr) at least 3 months apart and within 12 months before Screening, to define the rate of progression of CKD.
• Willing and able to refrain from use of non-steroidal drugs (NSAIDs) (including aspirin), clopidogrel, fish oil, dipyridamole, prasugrel, or platelet inhibitors for 7 days before and after both biopsy and implant.
• Willing and able to cooperate with all aspects of the study.
• Willing and able to give signed informed consent.

You may not qualify if:

• Type 1 diabetes mellitus (DM).
• History of renal transplant.
• HbA1c \> 10% at Screening.
• Hemoglobin levels \< 9 g/dL prior to implant.
• Known allergy to kanamycin or structurally similar aminoglycoside antibiotics.
• Abnormal coagulation status as measured by partial thromboplastin time (APTT), international normalized ratio (INR), and/or platelet count at Screening.
• Not a good candidate for the implantation procedure (based on the assessment of the investigator or operator) including patients who are morbidly obese, have BMI \> 45, have excessive fat surrounding the kidney, or who are otherwise at risk for serious complications.
• Clinically significant infection requiring parenteral antibiotics within 6 weeks of implantation.
• Patients with small kidneys (average size \< 9 cm) or only one kidney, as assessed by MRI or renal US within 1 year of screening.
• Patients with acute kidney injury or a rapid decline in renal function within 3 months prior to implantation.
• Patients with renal tumors, polycystic kidney disease, renal cysts or other anatomic abnormalities that would interfere with implantation procedure (e.g., cysts in the pathway of the injection for implantation), hydronephrosis, skin infection over proposed implantation sites, or evidence of a urinary tract infection.
• Female subjects who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of child bearing potential and not using a highly effective method of birth control (including sexual abstinence). Subjects must be willing to continue birth control methods throughout the course of the study.
• History of cancer within the past 3 years (excluding non-melanoma skin cancer and carcinoma in situ of the cervix).
• Life expectancy of less than 2 years.
• Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of animal (bovine, porcine) origin or anesthetic agents.

Sponsors & Collaborators

• Prokidney: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (1)

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; 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; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr William S Aronstein
• Organization: CTI

baronstein@ctifacts.com

5135989290

Study Officials

• Ashley Johns, MSHS

  Prokidney

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 17, 2015
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Locations

US (1)