Trial Outcomes & Findings for Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD) (NCT NCT02525263)

Results Overview

Procedure and/or product related adverse events (AE's) through 12 months following the final NKA implantation, as measured by AE reporting.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

12 months following final implantation

Results posted on

2021-04-23

Participant Flow

The one US patient who had previously received an NKA injection under a previous protocol for the previous sponsor was allowed to enroll in this trial.

The only enrolled patient was assigned to the only treatment arm. There was no significant event prior to assignment.

Participant milestones

Participant milestones
Measure	NKA Augment Second Dose This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NKA Augment Second Dose n=1 Participants This trial was a single-dose, single-arm, open-label trial. The only treatment arm was a percutaneous injection of NKA.
Age, Customized 59 years old	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NKA Augment Second Dose n=18 Adverse events This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
Procedure and/or Product Related Serious Adverse Events (AE's) Through 12 Months Following the Final NKA Implantation	2 Serious adverse events

PRIMARY outcome

Timeframe: 6 months following final cell implantation

Population: The single patient enrolled in the study was analyzed.

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.

Outcome measures

Outcome measures
Measure	NKA Augment Second Dose n=1 Participants This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
Serial Estimation of Glomerular Filtration Rate (GFR) Through 6 Months Following the Final Cell Implantation, as Measured by Serial Serum Creatinine. Final eGFR	11 mL/min/1.73 m2
Serial Estimation of Glomerular Filtration Rate (GFR) Through 6 Months Following the Final Cell Implantation, as Measured by Serial Serum Creatinine. Baseline eGFR	14 mL/min/1.73 m2

SECONDARY outcome

Timeframe: 12 months following last NKA implantation under this protocol

Population: Biomarkers were not analyzed for the one subject enrolled. There are no data for this outcome.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months following initial NKA implantation

Population: These data were not analyzed for the one patient enrolled.

Laboratory assessments of renal function (including eGFR, serum creatinine, and proteinuria) to assess changes in the rate of progression of renal disease; and effect of method of implantation on these parameters.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 18 months after first NKA implantation

Population: Quality of life data were not analyzed for the one patient enrolled.

Quality of life as measured by serial Kidney Disease Quality of Life survey obtained at baseline and at 1, 3, 6, 7, 9, 12, 15 and 18 months after a patient's first NKA implantation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months following initial NKA implantation

Population: The data for the lone subject were not formally analyzed.

Evaluation of renal structure over time as measured by imaging modalities including MRI and Scintigraphy.

Outcome measures

Outcome data not reported

Adverse Events

NKA Augment Second Dose

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NKA Augment Second Dose n=1 participants at risk This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
Cardiac disorders Worsening hypertension	100.0% 1/1 • Number of events 1 • 296 days.
Surgical and medical procedures Surgical pain of the left kidney	100.0% 1/1 • Number of events 1 • 296 days.

Other adverse events

Other adverse events
Measure	NKA Augment Second Dose n=1 participants at risk This was an open-label, single treatment art trial. A previously treated patient was enrolled in this trial to be administered a second dose of NKA via the percutaneous route.
Endocrine disorders Worsening of hyperparathyroidism	100.0% 1/1 • Number of events 1 • 296 days.
Renal and urinary disorders Worsening of chronic kidney disease	100.0% 1/1 • Number of events 1 • 296 days.

Additional Information

Dr William S Aronstein

CTI

Phone: 5135989290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place