Chronic Kidney DiseasePhase 1NCT01846715

Study of an Autologous Neo-Kidney Augment in Patients With Chronic Kidney Disease

A Phase 1 study testing Implantation of SRC in people with Chronic Kidney Disease, run by Tengion at 2 sites in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The primary purpose of this study is to assess the safety and optimal delivery of the Neo-Kidney Augment (NKA) when implanted at one site in a recipient kidney. NKA is made from expanded autologous, homologous, selected renal cells (SRC) obtained from the patient's kidney biopsy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Implantation of SRC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesSweden
Study dates: Apr 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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects, age 18 to 70 years on the date of informed consent.
Patients with estimated Glomerular Filtration Rate 15 - 60 mL/min at Screening due to intrinsic or "medical" renal disease (such as nephropathy due to type-2 diabetes, nephrosclerosis or chronic glomerulonephritis).
Mean systolic blood pressure between 105 and 160 mmHg, inclusive; mean diastolic blood pressure must be ≤90 mmHg. Patients with blood pressure outside of this range prior to implant, may be implanted if approved by the Medical Monitor.
Ongoing treatment with an angiotensin converting enzyme inhibitor and/or angiontensin receptor blocker, initiated at least 6 weeks prior to screening.
Minimum 3 month medical history of CKD progression as assessed by laboratory values.
Willing and able to refrain from use of NSAIDs (including aspirin) and clopidogrel for 10 days before and 10 days after 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 a renal transplant.
HbA1c ≥ 104 mmol/mol IFCC at Screening.
BMI <18.5 kg/m2 or >35 kg/m2 at Screening.
Abnormal coagulation status as measured by APTT, INR, fibrinogen and/or platelet count.
Ineligible for an MRI or renal scintigraphy (e.g. due to hypersensitivity or allergy) study based on the Karolinska University Hospital guidelines.

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Clinically significant infection requiring parenteral antibiotics within 6 weeks of biopsy or implantation.
CKD due to polycystic kidney disease, other renal structural abnormalities, myeloma kidney, history of nephroblastoma, post-streptococcal glomerulonephritis, pre- or postrenal component of CKD, and genetically based renal disease (e.g. Podocin mutations, renal agenesis).
Patients with small (< 10 cm) kidneys or only one kidney; patients with a history of highly echogenic kidneys. Patients with an average width of kidney cortex < 1.0 cm as estimated by MRI. Patients whose left kidney would not be acceptable for biopsy/implant as assessed by the Investigator based on results from screening procedures.
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). A highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner. Subjects must be willing to continue birth control methods throughout the course of the study.
History of cancer within the past 5 years (excluding non-melanoma skin cancer and carcinoma in situ of the cervix) or a condition highly likely to transform into malignancy during the course of the study.
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 results for any of the following (per Commission Directive 2006/17/EC) at Screening and Biopsy:
Viral Nucleic Acid Testing: Human Immunodeficiency Virus (HIV) 1 and 2 RNA, Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA
Viral Protein Testing: HBV surface antigen (HBsAg)
Viral Antibody Testing: Anti-HIV 1 and 2, Anti-HBV core antigen (Anti HBc), Anti-HCV antibody.
Confirmed active infection with Treponema pallidum.
Subjects with active tuberculosis (TB) requiring treatment in the past 3 years.
Immunocompromised subjects or patients receiving immunosuppressive agents (including patients treated for chronic glomerulonephritis) within 3 months of biopsy. [Note: inhaled corticosteroids and chronic low-dose corticosteroids [≤ 7.5mg per day] are permitted as are brief pulsed corticosteroids for intermittent symptoms (e.g. asthma).]
Subjects with uncontrolled diabetes (defined as metabolically unstable by the PI), 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.
Subjects with an albumin value < 25 g/L, and albumin/creatinine ratio greater than 3500mg/g at Screening or prior to Biopsy.
Patients with clinically significant hepatic disease (ALAT or ASAT > 5.0 x ULN) at Screening.
Patients with bleeding disorders or patients taking Coumarins (e.g.,Warfarin).
Any circumstance in which the investigator deems participation in the study is not in the subject's best interest.
Use of any investigational product (drug, biologic, or device) within 5 half-lives (drug, biologic) or 3 months, whichever is longer, without receiving prior written consent of the Medical Monitor.-

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

Karolinska Institute
Stockholm
Uppsala University Hospital
Uppsala

Other trials in Sweden

About this study

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)

Read the detailed description

Therapeutic intervention with NKA is intended to delay the need for renal replacement therapy (dialysis or transplant) which at this time, is inevitable in patients with CKD. NKA is composed of autologous, homologous selected renal cells (SRC) formulated in a Biomaterial (gelatin-based hydrogel). SRC are the biologically active component of NKA. Proof of principle for SRC as the biologically active component of NKA was established in multiple models of CKD. Based on nonclinical efficacy and safety data, a single NKA dose will be delivered to patients in this FIH clinical trial. This dose provides a minimum of a 1.5-fold safety margin over doses delivered safely in nonclinical studies. In addition, this dose demonstrated efficacy in a nonclinical disease model.

Conditions: Chronic Kidney Disease
Being tested: Implantation of SRC
Keywords: Kidney disease, Renal insufficiency, CKD, Autologous cell therapy
Medical subject headings: Renal Insufficiency, Chronic, Kidney Diseases, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantation of SRCBiological

Study groups in NCT01846715
Study group	Role	What they receive
NKA Treatment	Experimental	Patients will receive an implantation of autologous selected renal cells (SRC). Receives: Biological: Implantation of SRC

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of procedure and/or product related adverse events
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).
Measured: Between screening visit and 3 months post-implantation

Secondary outcomes (1)

Change in the rate of renal disease progression
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.
Measured: Baseline and 6 months post-implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Dec 2014

First posted3 May 2013 (estimated)
Study startApr 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01846715
Sponsor's protocol ID: TNG-CL010
Status last verified: Dec 2014
First submitted: 30 Apr 2013
Last updated: 11 Dec 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Disease trials

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 Delivery Optimization Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Chronic Kidney Disease (CKD)
ClinicalTrials.gov ID: NCT01846715
Acronym / sponsor ID: TNG-CL010
Conditions: Chronic Kidney Disease
Keywords: Kidney disease, Renal insufficiency, CKD, Autologous cell therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of funding
Enrolment: 6 participants (actual)
Lead sponsor: TengionIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 3 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NKA Treatment	Experimental	Biological: Implantation of SRCPatients will receive an implantation of autologous selected renal cells (SRC).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male and female subjects, age 18 to 70 years on the date of informed consent.
Patients with estimated Glomerular Filtration Rate 15 - 60 mL/min at Screening due to intrinsic or "medical" renal disease (such as nephropathy due to type-2 diabetes, nephrosclerosis or chronic glomerulonephritis).
Mean systolic blood pressure between 105 and 160 mmHg, inclusive; mean diastolic blood pressure must be ≤90 mmHg. Patients with blood pressure outside of this range prior to implant, may be implanted if approved by the Medical Monitor.
Ongoing treatment with an angiotensin converting enzyme inhibitor and/or angiontensin receptor blocker, initiated at least 6 weeks prior to screening.
Minimum 3 month medical history of CKD progression as assessed by laboratory values.

Key exclusion criteria (27 listed)

Type 1 diabetes mellitus (DM).
History of a renal transplant.
HbA1c ≥ 104 mmol/mol IFCC at Screening.
BMI <18.5 kg/m2 or >35 kg/m2 at Screening.
Abnormal coagulation status as measured by APTT, INR, fibrinogen and/or platelet count.

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
Implantation of SRC	Biological	NKA Treatment

Primary outcome

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).

1 secondary outcome

Change in the rate of renal disease progression
Time frame: Baseline and 6 months post-implantation

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
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Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 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 Implantation of SRC in people with Chronic Kidney Disease, run by Tengion at 2 sites in Sweden.

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 8 inclusion and 27 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 2 sites in Sweden. 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?

Occurrence of procedure and/or product related adverse events (time frame: Between screening visit and 3 months post-implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01846715.

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.