Chronic Kidney DiseasePhase 2RMCL-CL001NCT02525263
Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)
A Phase 2 study testing Neo-Kidney Augment in people with Chronic Kidney Disease and Type 2 Diabetes, run by Prokidney at 1 site in United States.
Trial summary
A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes
- 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
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females, age 30 - 70 years.
- Patients with type 2 diabetes mellitus (T2DM).
- Patients with diabetic nephropathy as the underlying cause of their renal disease.
- If not previously implanted with NKA, CKD defined as a GFR of 20 - 50 mL/min/1.73m2 inclusive. Ifs previously treated with a single NKA implantation, eGFR 15 to 60 mL/min may also enroll.
- Microalbuminuria (urinary albumin-creatinine ratio (UACR) ≥ 30 mg/g or urine albumin excretion ≥ 30 mg/day on 24 hour urine collection) not explained by an alternative diagnosis.
- Systolic blood pressure between 105 and 140 mmHg (inclusive) and diastolic blood pressure ≤90 mmHg.
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- Treatment with angiotensin inhibitor (ACEI) or angiotensin blocker (ARB) initiated at least 8 weeks prior to enrollment. Treatment must be stable for the 6 weeks prior to implant. Patients intolerant of ACEI or ARBs may be included if stable BP is within acceptable limits.
- Minimum of 2 measurements of eGFR or serum creatinine (sCr) at least 3 months apart and within 12 months before Screening, to define the rate of progression of CKD.
- Willing and able to refrain from use of non-steroidal drugs (NSAIDs) (including aspirin), clopidogrel, fish oil, dipyridamole, prasugrel, or platelet inhibitors for 7 days before and after both biopsy and implant.
- Willing and able to cooperate with all aspects of the study.
- Willing and able to give signed informed consent.
Who cannot join
- Type 1 diabetes mellitus (DM).
- History of renal transplant.
- HbA1c > 10% at Screening.
- Hemoglobin levels < 9 g/dL prior to implant.
- Known allergy to kanamycin or structurally similar aminoglycoside antibiotics.
- Abnormal coagulation status as measured by partial thromboplastin time (APTT), international normalized ratio (INR), and/or platelet count at Screening.
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- Not a good candidate for the implantation procedure (based on the assessment of the investigator or operator) including patients who are morbidly obese, have BMI > 45, have excessive fat surrounding the kidney, or who are otherwise at risk for serious complications.
- Clinically significant infection requiring parenteral antibiotics within 6 weeks of implantation.
- Patients with small kidneys (average size < 9 cm) or only one kidney, as assessed by MRI or renal US within 1 year of screening.
- Patients with acute kidney injury or a rapid decline in renal function within 3 months prior to implantation.
- Patients with renal tumors, polycystic kidney disease, renal cysts or other anatomic abnormalities that would interfere with implantation procedure (e.g., cysts in the pathway of the injection for implantation), hydronephrosis, skin infection over proposed implantation 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, or who are of child bearing potential and not using a highly effective method of birth control (including sexual abstinence). Subjects must be willing to continue birth control methods throughout 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 at the Screening Visit.
- Subjects requiring treatment for tuberculosis (TB) in the past 3 years.
- Immunocompromised subjects or patients receiving systemic immunosuppressive agents (including patients treated for chronic glomerulonephritis) within 3 months of implantation.
- Subjects with uncontrolled diabetes (defined as metabolically unstable by the PI), or with 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 elevated transaminases (ALT or AST > 3.0 x ULN) at Screening.
- 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).
- Any circumstance in which the investigator deems participation in the study is not in the subject's best interest.
- Use of any investigational product within 3 months of the implantation without receiving prior written consent of the Medical Monitor.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Phase II, Open-label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease
A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. All enrolled subjects will be treated with up to two injections of NKA at least 6 months apart.
Read the detailed description
A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). This is a Multi-center, prospective, open-label, single-group study. NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use. All enrolled subjects will be treated with up to two injections of NKA at least 6 months apart. Up to 30 subjects undergoing NKA injection will be enrolled into the study. Patients who have received a single injection of NKA under previous research protocols may enroll in this clinical trial to receive a single additional implantation. Patients who have never received an NKA injection may enroll in this clinical trial for up to a total of two (2) NKA injections, temporally spaced at least 6 months apart. All biopsies are to be taken from a single kidney, and all NKA injections are to be given into the kidney that was biopsied.
Patients who complete screening procedures satisfying all I/E criteria will be enrolled into the study immediately prior to the injection. Patients who do not meet all criteria before injection will be considered screen failures. Once a patient has been injected, the patient will have completed treatment and every effort should be made to ensure the patient completes all follow-up visits. Injection dates for the first 3 patients receiving their second NKA injection will be staggered by a minimum of 3 week intervals to allow for assessment of acute adverse events and other safety parameters by a Data Safety Monitoring Board (DSMB). At the completion of the follow-up visits, patients will continue in a long-term observational follow-up period. Patients will be followed for a total of 36 months following the last NKA injection under this protocol, whether the first or second injection.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Being tested
- Neo-Kidney Augment
- Keywords
- Neo-Kidney Augment, Type 2 Diabetes, Chronic Kidney Disease, Cell Therapy
- 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
NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use.
| Study group | Role | What they receive |
|---|---|---|
| Neo-Kidney Augment | Experimental | NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use. Receives: Biological: Neo-Kidney Augment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure and/or Product Related Serious Adverse Events (AE's) Through 12 Months Following the Final NKA Implantation
Procedure and/or product related adverse events (AE's) through 12 months following the final NKA implantation, as measured by AE reporting.
Measured: 12 months following final implantation
Serial Estimation of Glomerular Filtration Rate (GFR) Through 6 Months Following the Final Cell Implantation, as Measured by Serial Serum Creatinine.
The patient's serum creatinine was measured using a blood test at predetermined intervals and used to estimate the glomerular filtration rate as an indication of overall renal function.
Measured: 6 months following final cell implantation
Secondary outcomes (1)
Renal-specific Laboratory Assessments Through 12 Months Following the Last NKA Implantation Under This Protocol.
Renal-specific laboratory assessments through 12 months following the last NKA implantation under this protocol, whether first or second, as measured by renal specific biomarkers.
Measured: 12 months following last NKA implantation under this protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionAug 2017
Why it stopped: The single patient enrolled began hemodialysis treatments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prokidney
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
- Investigators
- Ashley Johns, MSHS, Study director, Prokidney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525263
- Sponsor's protocol ID
- RMCL-CL001
- Acronym
- RMCL-CL001
- Status last verified
- Mar 2021
- First submitted
- 30 Jul 2015
- Last updated
- 23 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02525263
- Acronym / sponsor ID
- RMCL-CL001 / RMCL-CL001
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Keywords
- Neo-Kidney Augment, Type 2 Diabetes, Chronic Kidney Disease, Cell Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The single patient enrolled began hemodialysis treatments.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ProkidneyIndustry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- Jul 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 23 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. All enrolled subjects will be treated with up to two injections of NKA at least 6 months apart.
Detailed description
A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). This is a Multi-center, prospective, open-label, single-group study. NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use. All enrolled subjects will be treated with up to two injections of NKA at least 6 months apart. Up to 30 subjects undergoing NKA injection will be enrolled into the study. Patients who have received a single injection of NKA under previous research protocols may enroll in this clinical trial to receive a single additional implantation. Patients who have never received an NKA injection may enroll in this clinical trial for up to a total of two (2) NKA injections, temporally spaced at least 6 months apart. All biopsies are to be taken from a single kidney, and all NKA injections are to be given into the kidney that was biopsied.
Patients who complete screening procedures satisfying all I/E criteria will be enrolled into the study immediately prior to the injection. Patients who do not meet all criteria before injection will be considered screen failures. Once a patient has been injected, the patient will have completed treatment and every effort should be made to ensure the patient completes all follow-up visits. Injection dates for the first 3 patients receiving their second NKA injection will be staggered by a minimum of 3 week intervals to allow for assessment of acute adverse events and other safety parameters by a Data Safety Monitoring Board (DSMB). At the completion of the follow-up visits, patients will continue in a long-term observational follow-up period. Patients will be followed for a total of 36 months following the last NKA injection under this protocol, whether the first or second injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neo-Kidney Augment | Experimental | Biological: Neo-Kidney AugmentNKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females, age 30 - 70 years.
- Patients with type 2 diabetes mellitus (T2DM).
- Patients with diabetic nephropathy as the underlying cause of their renal disease.
- If not previously implanted with NKA, CKD defined as a GFR of 20 - 50 mL/min/1.73m2 inclusive. Ifs previously treated with a single NKA implantation, eGFR 15 to 60 mL/min may also enroll.
- Microalbuminuria (urinary albumin-creatinine ratio (UACR) ≥ 30 mg/g or urine albumin excretion ≥ 30 mg/day on 24 hour urine collection) not explained by an alternative diagnosis.
Key exclusion criteria (24 listed)
- Type 1 diabetes mellitus (DM).
- History of renal transplant.
- HbA1c > 10% at Screening.
- Hemoglobin levels < 9 g/dL prior to 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 AugmentNKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use. | Biological | Neo-Kidney Augment |
Primary outcome
Procedure and/or Product Related Serious Adverse Events (AE's) Through 12 Months Following the Final NKA Implantation
Time frame: 12 months following final implantation
Procedure and/or product related adverse events (AE's) through 12 months following the final NKA implantation, as measured by AE reporting.
Serial Estimation of Glomerular Filtration Rate (GFR) Through 6 Months Following the Final Cell Implantation, as Measured by Serial Serum Creatinine.
Time frame: 6 months following final cell implantation
The patient's serum creatinine was measured using a blood test at predetermined intervals and used to estimate the glomerular filtration rate as an indication of overall renal function.
1 secondary outcome
Renal-specific Laboratory Assessments Through 12 Months Following the Last NKA Implantation Under This Protocol.
Time frame: 12 months following last NKA implantation under this protocol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Ashley Johns, MSHS study director
Prokidney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neo-Kidney Augment in people with Chronic Kidney Disease and Type 2 Diabetes, run by Prokidney at 1 site 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 11 inclusion and 24 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 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procedure and/or Product Related Serious Adverse Events (AE's) Through 12 Months Following the Final NKA Implantation (time frame: 12 months following final implantation). The study lists 2 primary outcomes in all. 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 23 Apr 2021.