Trial · NCT04009668
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
NCT04009668, Phase 2, Completed, University of Michigan; results first posted 2024-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease. Trials, record NCT04009668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04009668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
- NCT number
- NCT04009668
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- FSGS, MCD, Focal Segmental Glomerulosclerosis, Minimal Change Disease
- Interventions
- adalimumab
- First posted
- 2019-07-05
- Last updated
- 2024-10-30
- Results first posted
- 2024-10-30
- Limitations and caveats
Recruitment was launched in Dec. 2019 and was significantly impacted by the COVID-19 pandemic with most participants enrolling in 2022.~One participant was unable to attend the week 10 visit because of COVID-19 infection, and the week 8 biomarker results were used to determine the primary outcome.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Urine MCP1/Cr Levels | 10 Weeks | 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. |
| Primary | Change in Urine TIMP1/Cr Levels | 10 Weeks | TIMP1 is an established marker of intra-renal TNF pathway activation. A reduction in TIMP1 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. |
| Secondary | Incidence of Adverse Events (AEs) | 14 weeks | AEs for this outcome measure were classified using the following definitions: * Mild: no or mild symptoms, and not requiring intervention * Moderate: with minimal or local intervention, and limiting age-appropriate activities * Severe: intervention necessary and limiting age-appropriate activities but not immediately life-threatening, and requiring hospitalization or prolongation of hospitalization * Serious AE: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, pregnancy or congenital anomaly/birth defect. Some participants experienced multiple types of AE during the course of the trial. |
| Secondary | Change in Estimated Glomerular Filtration Rate (eGFR) | 10 Weeks | eGFR is a measure of kidney functioning based on a blood sample and clinical information to calculate it. Normal kidney function is greater than 90 ml/min/1.73 m2. Result data is the percent change in eGFR following the intervention. The lower the number shows the greater decline in kidney function. |
| Secondary | Change in Urine Protein Creatinine Ratio (UPCR) | 10 Weeks | UPCR is a measure of protein spillage from the kidney based on a urine specimen. Normal reference range is less than 0.03 mg/mg. Result is the percent change in UPCR following the intervention, with lower number showing less protein spilling from the kidney, reflecting better disease control. |
| Secondary | Proportion of Participants Who Achieved Both a Nadir Urine Protein Creatinine Ratio (UPCR) of Less Than 1.5 g/g and at Least a 40% Reduction From Baseline | 10 Weeks | UPCR is a measure of protein spillage from the kidney based on a urine specimen. Normal reference range is less than 0.03 mg/mg. Result is the count of participants who simultaneously met the criteria of having both a raw UPCR value of less than 1.5 g/g and at least a 40% reduction from baseline. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Urine MCP1/Cr Levels | 10 Weeks | ng/mg | MEDIAN | |
| PRIMARY | Change in Urine TIMP1/Cr Levels | 10 Weeks | ng/mg | MEDIAN | |
| SECONDARY | Incidence of Adverse Events (AEs) | 14 weeks | Adverse Event | NUMBER | |
| SECONDARY | Change in Estimated Glomerular Filtration Rate (eGFR) | 10 Weeks | Percent Change | MEDIAN | |
| SECONDARY | Change in Urine Protein Creatinine Ratio (UPCR) | 10 Weeks | Percent Change | MEDIAN | |
| SECONDARY | Proportion of Participants Who Achieved Both a Nadir Urine Protein Creatinine Ratio (UPCR) of Less Than 1.5 g/g and at Least a 40% Reduction From Baseline | 10 Weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Urine MCP1/Cr Levels | Adalimumab | Baseline | 5.57 | Inter-Quartile Range 0.79 to 6.61 | ng/mg |
| Change in Urine MCP1/Cr Levels | Adalimumab | Week 10 | 2.89 | Inter-Quartile Range 1.36 to 7.14 | ng/mg |
| Change in Urine TIMP1/Cr Levels | Adalimumab | Baseline | 41.34 | Inter-Quartile Range 3.64 to 75.38 | ng/mg |
| Change in Urine TIMP1/Cr Levels | Adalimumab | Week 10 | 31.36 | Inter-Quartile Range 4.39 to 146.86 | ng/mg |
| Incidence of Adverse Events (AEs) | Adalimumab | Mild AEs | 7 | Adverse Event | |
| Incidence of Adverse Events (AEs) | Adalimumab | Moderate AEs | 4 | Adverse Event | |
| Incidence of Adverse Events (AEs) | Adalimumab | Severe AEs | 1 | Adverse Event | |
| Incidence of Adverse Events (AEs) | Adalimumab | Serious AEs | 10 | Adverse Event | |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Adalimumab | -28.90 | Inter-Quartile Range -30.50 to -12.18 | Percent Change | |
| Change in Urine Protein Creatinine Ratio (UPCR) | Adalimumab | -11.60 | Inter-Quartile Range -23.45 to -9.28 | Percent Change |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adalimumab | 7 | |
| Overall Study | COMPLETED | Adalimumab | 7 | |
| Overall Study | NOT COMPLETED | Adalimumab | 0 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Adalimumab | 1 | 7 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Adalimumab | 1 | 7 | 1 |
| other | Volume depletion | General disorders | Adalimumab | 1 | 7 | 1 |
| other | COVID-19 | Infections and infestations | Adalimumab | 2 | 7 | 2 |
| other | Rhinovirus | Infections and infestations | Adalimumab | 1 | 7 | 1 |
| other | Increased edema | Renal and urinary disorders | Adalimumab | 1 | 7 | 1 |
| other | eGFR decline (greater than 25% since baseline) | Renal and urinary disorders | Adalimumab | 4 | 7 | 4 |
| other | Rash | Skin and subcutaneous tissue disorders | Adalimumab | 1 | 7 | 1 |
| serious | Influenza | Infections and infestations | Adalimumab | 1 | 7 | 1 |
| serious | Edema | Renal and urinary disorders | Adalimumab | 1 | 7 | 5 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adalimumab | 0 | 7 |
| Total, other adverse events | Adalimumab | 5 | 7 |
| Total, serious adverse events | Adalimumab | 1 | 7 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04009668
GET https://conductscience.org/api/trials/v1/NCT04009668/registered