Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Stromedix, Inc.
ClinicalTrials.gov Identifier:
NCT00878761
First received: April 6, 2009
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, single followed by multiple dose, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact of STX-100 on gene and protein expression for αvβ6 related and TGF-β-inducible genes (including tubulointerstitial injury, epithelial function, and IF/TA related genes) in renal transplant patients with biopsy.


Condition Intervention Phase
Chronic Allograft Dysfunction
Biological: STX-100
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind, Placebo-Controlled, Single and Multiple Dose, Dose-Escalation Study of STX 100 in Renal Transplant Patients With Biopsy Proven Interstitial Fibrosis and Tubular Atrophy (IF/TA)

Resource links provided by NLM:


Further study details as provided by Stromedix, Inc.:

Primary Outcome Measures:
  • Safety as measured by adverse events [ Time Frame: 25 weeks from first dosing (per cohort) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STX-100 (0.03mg/kg)
8 patients (6 active and 2 placebo)
Biological: STX-100
SC, single dose followed by multiple dose
Experimental: STX-100 (0.1mg/kg)
8 patients (6 active and 2 placebo)
Biological: STX-100
SC, single dose followed by multiple dose
Experimental: STX-100 (0.3mg/kg)
16 patients (12 active and 4 placebo)
Biological: STX-100
SC, single dose followed by multiple dose
Experimental: STX-100 (1mg/kg)
16 patients (12 active and 4 placebo)
Biological: STX-100
SC, single dose followed by multiple dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consenting adult patients, 18 (or the legal age of consent) to 65 years old, male or female.
  • eGFR ≥ 25 ml/min (Cockcroft-Gault formula).
  • Six to 60 months post renal transplant at the initiation of screening.
  • Qualifying renal biopsy obtained within 8 weeks prior to randomization with histologic evidence of ≥ Grade 2 IF/TA (Banff score) without morphologic evidence of a treatable etiology (e.g., BK virus nephropathy, chronic obstruction).
  • Adequate bone marrow and liver function
  • Weight between 40-110 kg.
  • Female patients must be surgically sterile, postmenopausal (minimum 1 year without menses and verified by follicular-stimulating hormone [FSH] levels), or agree to use contraception from the time of signing the informed consent form through 16 weeks following the last injection of study medication. Male patients must also agree to use birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through 16 weeks following the last injection of study medication.

Exclusion Criteria:

  • Recipient of a multi-organ transplant.
  • History of T-cell mediated rejection (TCMR) within 3 months prior to randomization.
  • Patients who are receiving high dose corticosteroids at the time of screening.
  • Histologic evidence of acute TCMR (≥ Banff Grade 1A) on a qualifying renal biopsy for this study. Patients with 'borderline' changes (Banff criteria) on a qualifying renal biopsy are eligible for this study if the Principal Investigator believes treatment for TCMR is not warranted.
  • Prior or current histologic evidence of polyomavirus BK virus nephropathy.
  • Any histologic finding on the qualifying renal biopsy that the Investigator believes warrants modifying the patient's current therapy.
  • Evidence of active tissue invasive cytomegalovirus or Epstein-Barr virus infection.
  • History of malignancy, including carcinoma or post-transplant lymphoproliferative disorder.
  • History of chronic pulmonary disease or smoker within the past 5 years or more than 15 pack-years exposure.
  • Serious local infection or systemic infection within 3 months prior to screening.
  • Surgery within 3 months prior to Day 1 (other than minor cosmetic surgery, minor dental procedures, or percutaneous kidney transplant biopsy).
  • Positive test for HBsAg, HCV, or HIV antibody at screening.
  • Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month prior to dosing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878761

Locations
United States, Massachusetts
Stromedix Investigative Site
Cambridge, Massachusetts, United States, 02141
Sponsors and Collaborators
Stromedix, Inc.
Investigators
Study Chair: Bradley Maroni, MD Stromedix, Inc.
  More Information

No publications provided

Responsible Party: Bradley Maroni, MD, Stromedix, Inc
ClinicalTrials.gov Identifier: NCT00878761     History of Changes
Other Study ID Numbers: STX-002
Study First Received: April 6, 2009
Last Updated: May 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Stromedix, Inc.:
Renal transplant
Interstitial fibrosis and tubular atrophy
Chronic allograft dysfunction
Chronic allograft nephropathy
kidney transplant

Additional relevant MeSH terms:
Fibrosis
Lung Diseases, Interstitial
Atrophy
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014