Chronic Allograft DysfunctionPhase 2NCT00878761
Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)
A Phase 2 study testing STX-100 in people with Chronic Allograft Dysfunction, run by Stromedix, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Allograft Dysfunction
- What is being tested?
- STX-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stromedix Investigative Site
Cambridge, Massachusetts, 02141
About this study
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)
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.
- Conditions
- Chronic Allograft Dysfunction
- Being tested
- STX-100
- Keywords
- Renal transplant, Interstitial fibrosis and tubular atrophy, Chronic allograft dysfunction, Chronic allograft nephropathy, kidney transplant
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STX-100Biological
SC, single dose followed by multiple dose
| Study group | Role | What they receive |
|---|---|---|
| STX-100 (0.03mg/kg) | Experimental | 8 patients (6 active and 2 placebo) Receives: Biological: STX-100 |
| STX-100 (0.1mg/kg) | Experimental | 8 patients (6 active and 2 placebo) Receives: Biological: STX-100 |
| STX-100 (0.3mg/kg) | Experimental | 16 patients (12 active and 4 placebo) Receives: Biological: STX-100 |
| STX-100 (1mg/kg) | Experimental | 16 patients (12 active and 4 placebo) Receives: Biological: STX-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by adverse events
Measured: 25 weeks from first dosing (per cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startSep 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Allograft DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stromedix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bradley Maroni, MD, Study chair, Stromedix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878761
- Sponsor's protocol ID
- STX-002
- Status last verified
- May 2011
- First submitted
- 6 Apr 2009
- Last updated
- 23 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abbad L, Esteve E, Chatziantoniou C. Advances and challenges in kidney fibrosis therapeutics. Nat Rev Nephrol. 2025 May;21(5):314-329. doi: 10.1038/s41581-025-00934-5. Epub 2025 Feb 11.
PubMed 39934355
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00878761
- Acronym / sponsor ID
- STX-002
- Conditions
- Chronic Allograft Dysfunction
- Keywords
- Renal transplant, Interstitial fibrosis and tubular atrophy, Chronic allograft dysfunction, Chronic allograft nephropathy, kidney transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Stromedix, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| STX-100 (0.03mg/kg) | Experimental | Biological: STX-1008 patients (6 active and 2 placebo) |
| STX-100 (0.1mg/kg) | Experimental | Biological: STX-1008 patients (6 active and 2 placebo) |
| STX-100 (0.3mg/kg) | Experimental | Biological: STX-10016 patients (12 active and 4 placebo) |
| STX-100 (1mg/kg) | Experimental | Biological: STX-10016 patients (12 active and 4 placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STX-100SC, single dose followed by multiple dose | Biological | STX-100 (0.03mg/kg), STX-100 (0.1mg/kg), STX-100 (0.3mg/kg), STX-100 (1mg/kg) |
Primary outcome
Safety as measured by adverse events
Time frame: 25 weeks from first dosing (per cohort)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2011.
- Derived from this study: PubMed 39934355Abbad L, Esteve E, Chatziantoniou C. Advances and challenges in kidney fibrosis therapeutics. Nat Rev Nephrol. 2025 May;21(5):314-329. doi: 10.1038/s41581-025-00934-5. Epub 2025 Feb 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Maroni, MD study chair
Stromedix, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STX-100 in people with Chronic Allograft Dysfunction, run by Stromedix, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by adverse events (time frame: 25 weeks from first dosing (per cohort)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2011.