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)

Stromedix, Inc.1 site in 1 country48 target enrollmentSeptember 2010

ConditionsChronic Allograft Dysfunction

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Chronic Allograft Dysfunction
Sponsor: Stromedix, Inc.
Enrollment: 48
Locations: 1
Primary Endpoint: Safety as measured by adverse events
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

December 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stromedix, Inc.

Eligibility 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.