- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02008851
A Phase 1, Open-label Safety Study of NKA in Patients With Type 2 Diabetes
December 10, 2014 updated by: Tengion
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Medicine
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Louisiana
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New Orleans, Louisiana, United States, 70112
- LSU Health Care Services
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Massachusetts
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Boston, Massachusetts, United States, 02120
- Brigham & Women's Hospital
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- UNC Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37235
- Vanderbilt University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implantation of Neo-kidney Augment
Patients receiving one dose (implant) of NKA into the left kidney
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Injection of 3.0 x 10e6 selected renal cells into the left kidney of the patient
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of adverse events related to study procedures or investigational product
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of renal-specific adverse events
Time Frame: 12 months
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12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in renal function over time
Time Frame: 12 months
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Exploratory objectives include assessment of renal function over time; e.g., glomerular filtration rate (GFR), serum creatinine, and proteinuria.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eric McAllister, MD, DPhil, Tengion, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 6, 2013
First Submitted That Met QC Criteria
December 6, 2013
First Posted (Estimate)
December 11, 2013
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TNG-CL011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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