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This study has been withdrawn prior to enrollment.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

April 6, 2009
May 20, 2011
September 2010
October 2011   (final data collection date for primary outcome measure)
Safety as measured by adverse events [ Time Frame: 25 weeks from first dosing (per cohort) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00878761 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Allograft Dysfunction
Biological: STX-100
SC, single dose followed by multiple dose
  • Experimental: STX-100 (0.03mg/kg)
    8 patients (6 active and 2 placebo)
    Intervention: Biological: STX-100
  • Experimental: STX-100 (0.1mg/kg)
    8 patients (6 active and 2 placebo)
    Intervention: Biological: STX-100
  • Experimental: STX-100 (0.3mg/kg)
    16 patients (12 active and 4 placebo)
    Intervention: Biological: STX-100
  • Experimental: STX-100 (1mg/kg)
    16 patients (12 active and 4 placebo)
    Intervention: Biological: STX-100
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
48
December 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00878761
STX-002
Yes
Bradley Maroni, MD, Stromedix, Inc
Stromedix, Inc.
Not Provided
Study Chair: Bradley Maroni, MD Stromedix, Inc.
Stromedix, Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP