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
Verified date | December 2014 |
Source | Tengion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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 . |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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 |
Lead Sponsor | Collaborator |
---|---|
Tengion |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Terminated |
NCT04043026 -
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
|
||
Completed |
NCT05318014 -
Low-protein Formula Supplements in Chronic Kidney Disease
|
N/A | |
Active, not recruiting |
NCT06071065 -
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
|
N/A | |
Completed |
NCT02878317 -
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
|
||
Not yet recruiting |
NCT06039254 -
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
|
Phase 1 | |
Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|
||
Completed |
NCT02875886 -
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Completed |
NCT02756520 -
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
|
||
Completed |
NCT02896309 -
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
|
N/A | |
Completed |
NCT02836574 -
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
|
Phase 2 | |
Withdrawn |
NCT02885545 -
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
|
Phase 4 | |
Active, not recruiting |
NCT02483039 -
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
|
N/A | |
Terminated |
NCT02543177 -
Optimised Procedure in Patients With NSTEMI and CKD
|
N/A | |
Completed |
NCT02992548 -
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT02369549 -
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
|
Phase 3 | |
Recruiting |
NCT02205944 -
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
|
N/A | |
Active, not recruiting |
NCT02231138 -
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
|
Phase 4 |