A Phase 1, Open-label Safety Study of NKA in Patients With Type 2 Diabetes

Chronic Kidney Disease Clinical Trial

Official title:

A Phase 1, Open-Label Safety and Tolerability Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02008851
• Other study ID #: TNG-CL011
• Status: Terminated
• Phase: Phase 1
• First received: December 6, 2013
• Last updated: December 10, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Tengion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if selected renal cells, obtained by biopsy from a patient with chronic kidney disease (CKD) and Type 2 Diabetes (i.e., autologous cells) can be safely implanted back into the patient.

Description:

This is a Phase 1 safety and tolerability study to determine if NKA, manufactured from a patient's renal biopsy tissue, can be safely implanted back into the kidney of the patient. Patients must have CKD and Type 2 Diabetes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes mellitus (T2DM).

• Patients with CKD defined as glomerular filtration rate (GFR) of 20 - 50 mL/min/1.73m2, inclusive.

• Microalbuminuria that cannot be explained by an alternative diagnosis. Microalbuminuria is defined as a urinary albumin-creatinine ration (UACR) = 30 mg/g or urine albumin excretion = 30 mg/day on 24 hour urine collection.

• Ongoing treatment with ACEi or ARB. Patients who are intolerant may be included as long as they have stable blood pressure.

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

• The patient should have historical data to provide a reasonable estimate of the rate of progression of CKD

Exclusion Criteria:

• Type 1 diabetes mellitus (DM).

• History of a renal transplant.

• HbA1c > 10% at Screening.

• Hemoglobin levels < 9 g/dL prior to biopsy or implant.

• Known allergy to kanamycin or structurally similar aminoglycoside antibiotics.

• Abnormal coagulation status as measured by activated partial prothrombin time, international normalized ratio (INR), and/or platelet count.

• Ineligible for a biopsy (e.g., based on size or cortical depth), MRI or renal scintigraphy study (e.g. due to hypersensitivity or allergy) according to standard site practices.

• Not a good candidate for laparoscopic surgical procedure (based on the assessment of the surgeon who will be performing the implant), including patients who are morbidly obese, have excessive fat surrounding the kidney, have a BMI > 45, or who are otherwise at excessive risk for serious complications.

• Clinically significant infection requiring parenteral antibiotics within 6 weeks of biopsy or implantation.

• Patients with small kidneys (average size < 9 cm) or only one kidney. Patients with a rapid decline in renal function over the last 3 months prior to biopsy or acute kidney injury.

• Patients with any of the following conditions prior to biopsy: renal tumors, polycystic kidney disease, renal cysts or other anatomic abnormalities that would interfere with the biopsy or implantation procedure (e.g., cysts in the pathway of the injection for implantation), hydronephrosis, skin infection over proposed biopsy 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.

• 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.

• Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) assessed.

• Subjects with active tuberculosis (TB) requiring treatment in the past 3 years.

• Immunocompromised subjects or patients receiving immunosuppressive agents.

• Subjects with uncontrolled diabetes, incapacitating cardiac and/or pulmonary disorders.

• 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.

• Patients with clinically significant hepatic disease.

• 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).

• Use of any investigational product within 3 months of the biopsy .

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• Neo-kidney augment
Injection of 3.0 x 10e6 selected renal cells into the left kidney of the patient

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	UNC Medical Center	Chapel Hill	North Carolina
United States	University of Chicago Medicine	Chicago	Illinois
United States	Vanderbilt University	Nashville	Tennessee
United States	LSU Health Care Services	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tengion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in renal function over time	Exploratory objectives include assessment of renal function over time; e.g., glomerular filtration rate (GFR), serum creatinine, and proteinuria.	12 months	No
Primary	Number of adverse events related to study procedures or investigational product		12 months	No
Secondary	Number of renal-specific adverse events		12 months	No