Clinical trial · Interventional
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
Precision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Adalimumab, a treatment which blocks tumor necrosis factor (TNF), was tested to see if it changed levels of urine biomarker levels, tissue inhibitor of metalloprotease-1 (TIMP1), and monocyte chemoattractant protein-1 (MCP1). Results may help develop individualized treatment options for future patients with TNF-driven focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Focal Segmental Glomerulosclerosis | — | UNRESOLVED | — |
| FSGS | — | UNRESOLVED | — |
| MCD | — | UNRESOLVED | — |
| Minimal Change Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adalimumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- adalimumab
- description
- Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously
- interventionNames
- Drug: adalimumab
Primary outcomes (2)
- measure
- Change in Urine MCP1/Cr Levels
- timeFrame
- 10 Weeks
- description
- MCP1 is an established marker of intra-renal TNF pathway activation. A reduction in MCP1 reflects a reduction in the activation of the TNF pathway in the kidney. Values were measured by enzyme-linked immunosorbent assay (ELISA) testing and standardized over serum creatinine.
- measure
- Change in Urine TIMP1/Cr Levels
- timeFrame
- 10 Weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Kidney biopsy confirmed Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD) * For Minimal Change Disease patients only, history of resistance to corticosteroid therapy * Increased urinary excretion of biomarkers of Tumor Necrosis Factor (TNF) activation (MCP1/Cr and/ or TIMP1/Cr) at study screening * eGFR\>30 ml/min/1.73 m2 at screening * Urine protein:creatinine ratio ≥1.5 g/g at screening * Weight \>15 kg * Stable therapy with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and oral immunosuppression agents for at least 30 days prior to enrollment * Birth control use in females of child bearing potential * Informed consent and assent if applicable Exclusion Criteria: * Kidney or other solid organ or bone marrow transplant recipient * Allergy or intolerance to investigational agent * Secondary Focal Segmental Glomerulosclerosis (FSGS) * Severe obesity * Live virus vaccine in the past 3 months * Malignancy, current or in the past 5 years * Active local or systemic bacterial, fungal or viral infection * Active or latent Hepatitis B, Hepatitis C, HIV, or tuberculosis * History of demyelinating disease, e.g. Multiple Sclerosis or Guillain-Barre * History of heart failure * Active liver disease * Systemic lupus erythematosus or ANA \> 1:80 * History of inflammatory bowel disease, e.g. ulcerative colitis or Crohns disease * Cyclophosphamide in past 90 days, Rituximab in the past 180 days * Pregnancy or nursing * Blood white blood cell count \<4,500/mm3; Hg \<9 g/dL; Platelet count \<150,000/mm3 at enrollment. - Use of an erythropoiesis stimulating agent will not be an exclusion criterion. * Concurrent use of interleukin-1 antagonist (Anakinra), other TNF blocking agent, methotrexate or abatacept * Diabetes Mellitus
References
Publications (1)
- DERIVEDTrachtman H, Modi ZJ, Ju W, Lee E, Chinnakotla S, Massengill S, Sedor J, Mariani L, Zhai Y, Hao W, Desmond H, Eddy S, Ramani K, Spino C, Kretzler M. Precision Medicine Proof-of-Concept Study of a TNF Inhibitor in FSGS and Treatment-Resistant Minimal Change Disease. Kidney360. 2025 Feb 1;6(2):284-295. doi: 10.34067/KID.0000000635. Epub 2024 Nov 18. PMID 39808779