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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02525263
• Date of registration: 30/07/2015
• Prospective Registration: Yes
• Primary sponsor: inRegen
• Public title: Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD) RMCL-CL001
• Scientific title: 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
• Date of first enrolment: July 2016
• Target sample size: 1
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02525263
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Sweden, United States

Contacts

• Name: Ashley Johns, MSHS
• Affiliation: inRegen

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males and females, age 30 - 70 years.

2. Patients with type 2 diabetes mellitus (T2DM).

3. Patients with diabetic nephropathy as the underlying cause of their renal disease.

4. 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.

5. 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.

6. Systolic blood pressure between 105 and 140 mmHg (inclusive) and diastolic blood
pressure =90 mmHg.

7. 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.

8. 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.

9. 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.

10. Willing and able to cooperate with all aspects of the study.

11. Willing and able to give signed informed consent.

Exclusion Criteria:

1. Type 1 diabetes mellitus (DM).

2. History of renal transplant.

3. HbA1c > 10% at Screening.

4. Hemoglobin levels < 9 g/dL prior to implant.

5. Known allergy to kanamycin or structurally similar aminoglycoside antibiotics.

6. Abnormal coagulation status as measured by partial thromboplastin time (APTT),
international normalized ratio (INR), and/or platelet count at Screening.

7. 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.

8. Clinically significant infection requiring parenteral antibiotics within 6 weeks of
implantation.

9. Patients with small kidneys (average size < 9 cm) or only one kidney, as assessed by
MRI or renal US within 1 year of screening.

10. Patients with acute kidney injury or a rapid decline in renal function within 3 months
prior to implantation.

11. 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.

12. 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.

13. History of cancer within the past 3 years (excluding non-melanoma skin cancer and
carcinoma in situ of the cervix).

14. Life expectancy of less than 2 years.

15. Any contraindication or known anaphylactic or severe systemic reaction to either human
blood products or materials of animal (bovine, porcine) origin or anesthetic agents.

16. Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis
C Virus (HCV) assessed at the Screening Visit.

17. Subjects requiring treatment for tuberculosis (TB) in the past 3 years.

18. Immunocompromised subjects or patients receiving systemic immunosuppressive agents
(including patients treated for chronic glomerulonephritis) within 3 months of
implantation.

19. Subjects with uncontrolled diabetes (defined as metabolically unstable by the PI), or
with incapacitating cardiac and/or pulmonary disorders.

20. History of active alcohol and/or drug abuse that in the investigator's assessment
would impair the subject's ability to comply with the protocol.

21. Patients with elevated transaminases (ALT or AST > 3.0 x ULN) at Screening.

22. Patients with bleeding disorders that would, in the opinion of the Investigator,
interfere with the performance of study procedures; patients taking coumarins (e.g.
Warfarin) or other anticoagulants (e.g. enoxaparin or direct thrombin inhibitors).

23. Any circumstance in which the investigator deems participation in the study is not in
the subject's best interest.

24. Use of any investigational product within 3 months of the implantation without
receiving prior written consent of the Medical Monitor.



Age minimum: 30 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Chronic Kidney Disease

Intervention(s)

Biological: Neo-Kidney Augment

Primary Outcome(s)

Serial estimation of glomerular filtration rate (GFR) through 6 months following the final cell implantation, as measured by serial Serum Creatinine. [Time Frame: 6 months following final cell implantation]

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

Secondary Outcome(s)

Renal-specific laboratory assessments through 12 months following the last NKA implantation under this protocol, whether first or second, as measured by renal specific biomarkers. [Time Frame: 12 months following last NKA implantation under this protocol]

Secondary ID(s)

RMCL-CL001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CTI Clinical Trial and Consulting Services