Chronic Kidney DiseasePhase 1NCT02008851
A Phase 1, Open-label Safety Study of NKA in Patients With Type 2 Diabetes
A Phase 1 study testing Neo-kidney augment in people with Chronic Kidney Disease, run by Tengion at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Neo-kidney augment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2013to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 23Show fewer
- 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 .
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02120
UNC Medical Center
Chapel Hill, North Carolina, 27514
University of Chicago Medicine
Chicago, Illinois, 60637
Vanderbilt University
Nashville, Tennessee, 37235
LSU Health Care Services
New Orleans, Louisiana, 70112
About this study
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
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Neo-kidney augment
- Keywords
- Chronic kidney disease, Type 2 Diabetes, Neo-kidney augment, Regenerative medicine
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-kidney augmentBiological
Injection of 3.0 x 10e6 selected renal cells into the left kidney of the patient
| Study group | Role | What they receive |
|---|---|---|
| Implantation of Neo-kidney Augment | Experimental | Patients receiving one dose (implant) of NKA into the left kidney Receives: Biological: Neo-kidney augment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events related to study procedures or investigational product
Measured: 12 months
Secondary outcomes (1)
Number of renal-specific adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tengion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric McAllister, MD, DPhil, Study director, Tengion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008851
- Sponsor's protocol ID
- TNG-CL011
- Status last verified
- Dec 2014
- First submitted
- 6 Dec 2013
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02008851
- Acronym / sponsor ID
- TNG-CL011
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Type 2 Diabetes, Neo-kidney augment, Regenerative medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- TengionIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of Neo-kidney Augment | Experimental | Biological: Neo-kidney augmentPatients receiving one dose (implant) of NKA into the left kidney |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-kidney augmentInjection of 3.0 x 10e6 selected renal cells into the left kidney of the patient | Biological | Implantation of Neo-kidney Augment |
Primary outcome
Number of adverse events related to study procedures or investigational product
Time frame: 12 months
1 secondary outcome
Number of renal-specific adverse events
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric McAllister, MD, DPhil study director
Tengion, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neo-kidney augment in people with Chronic Kidney Disease, run by Tengion at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events related to study procedures or investigational product (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.