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

NCT02008851 | Terminated Phase 1 DMC

• 1 other identifier: TNG-CL011
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; Type 2 Diabetes; Neo-kidney augment; Regenerative medicine

Outcome Measures

Primary Outcomes (1)

• Number of adverse events related to study procedures or investigational product

  12 months

Secondary Outcomes (1)

• Number of renal-specific adverse events

  12 months

Other Outcomes (1)

• Changes in renal function over time

  12 months

Study Arms (1)

Implantation of Neo-kidney Augment

EXPERIMENTAL

Patients receiving one dose (implant) of NKA into the left kidney

Biological: Neo-kidney augment

Interventions

Neo-kidney augment BIOLOGICAL

Injection of 3.0 x 10e6 selected renal cells into the left kidney of the patient

Implantation of 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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tengion: lead

Study Sites (5)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

LSU Health Care Services

New Orleans, Louisiana, 70112, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02120, United States

Location

UNC Medical Center

Chapel Hill, North Carolina, 27514, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, 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

Study Officials

• Eric McAllister, MD, DPhil

  Tengion, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (5)