Study of an Autologous Neo-Kidney Augment in Patients With Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT01846715|
Recruitment Status : Terminated (lack of funding)
First Posted : May 3, 2013
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Biological: Implantation of SRC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label Safety and Delivery Optimization Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Chronic Kidney Disease (CKD)|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: NKA Treatment
Patients will receive an implantation of autologous selected renal cells (SRC).
Biological: Implantation of SRC
- Occurrence of procedure and/or product related adverse events [ Time Frame: Between screening visit and 3 months post-implantation ]The primary endpoint of the study is the occurrence of procedure and/or product related adverse events (AEs) through three months post-implantation. The primary outcome measures are procedure- and/or NK product-related AEs through 3 months post-implantation. Procedure related AEs include events considered related to the surgical procedures, biopsy or implantation of NKA including HARS, and not to other study-specific procedures (e.g., MRI or blood draws).
- Change in the rate of renal disease progression [ Time Frame: Baseline and 6 months post-implantation ]The secondary endpoint of the study is the change in the rate of progression of renal insufficiency, as measured by laboratory tests of renal function. The secondary outcome measures are laboratory assessments of renal function to assess changes in the rate of progression of renal insufficiency for each patient. Specifically, eGFR (based on cystatin-C and iohexol clearance), sCr, and ACR will be followed for 6 months to assess the post-implant rate of change compared to pre-implant changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846715
|Uppsala University Hospital|