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)

NCT00878761•Stromedix, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (1)

Stromedix Investigative Site

Cambridge, Massachusetts, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

December 1, 2011

Last Updated

May 23, 2011

Enrollment

ESTIMATED participants

Conditions

Chronic Allograft Dysfunction

Interventions

STX-100

BIOLOGICAL