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

NCT01846715 | Terminated Phase 1

• 1 other identifier: TNG-CL010
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

Kidney disease; Renal insufficiency; CKD; Autologous cell therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  Between screening visit and 3 months post-implantation

Secondary Outcomes (1)

• Change in the rate of renal disease progression

  Baseline and 6 months post-implantation

Study Arms (1)

NKA Treatment

EXPERIMENTAL

Patients will receive an implantation of autologous selected renal cells (SRC).

Biological: Implantation of SRC

Interventions

Implantation of SRC BIOLOGICAL

NKA Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Tengion: lead

Study Sites (2)

Karolinska Institute

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Renal Insufficiency

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

SE (2)