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

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ClinicalTrials.gov Identifier: NCT00878761
Recruitment Status : Withdrawn
First Posted : April 9, 2009
Last Update Posted : May 23, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Allograft Dysfunction Biological: STX-100 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : September 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Safety as measured by adverse events [ Time Frame: 25 weeks from first dosing (per cohort) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bradley Maroni, MD, Stromedix, Inc
ClinicalTrials.gov Identifier: NCT00878761     History of Changes
Other Study ID Numbers: STX-002
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011

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
Atrophy
Lung Diseases, Interstitial
Pathologic Processes
Pathological Conditions, Anatomical
Lung Diseases
Respiratory Tract Diseases