Trial · NCT00007475
Permeability Factor in Focal Segmental Glomerulosclerosis
NCT00007475, Phase 1, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2016-02-10
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ConductScience Library. Permeability Factor in Focal Segmental Glomerulosclerosis. Trials, record NCT00007475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00007475
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Permeability Factor in Focal Segmental Glomerulosclerosis
- NCT number
- NCT00007475
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- Plasma exchange, Cyclophosphamide
- First posted
- 2000-12-25
- Last updated
- 2016-02-10
- Results first posted
- 2016-02-10
- Limitations and caveats
Note: definitive FSGS Permeability Factor (FPF) assays still in development. Data/samples transferred to the NIH-CC Glomerulosclerosis Consolidation protocol: focus on cardiotrophin like cytokine 1 \& antibodies to a panel of podocyte proteins as FPF.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | every 3 months up to a year followed with native kidneys | Outcomes for FSGS occurring in native kidneys: A. Complete remission: proteinuria \<0.3 g/d ; B. Partial remission: proteinuria between 0.3 and 2 g/d ; C. Incomplete response: proteinuria between 2 and 3.5 g/d ; D. Relapse: return to proteinuria ≥3.5 g/d ; Note that counts within each category A-D may be summarized relative to remaining categories, as a proportion (relative to complement of the whole group count) with calculations implicitly based on zero/one valued binary variables, whose means are proportions, so to report 95% confidence intervals calculated using an exact binomial distribution. |
| Secondary | Comparison of RNA Expression Profiles in PBMC From Patients With FPF, Without FPF and Control Subjects | End of study | No RNA expression profiles have been obtained as FSGS Permeability Factor (FPF) levels NOT available -- its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial. Note that provisional values (targeting current candidate molecule: cardiotrophin-like cytokine 1) were assayed for 3 of the first 4 enrollees using assay by Dr. Virginia Savin, whose lab is actively investigating a molecular identification of FPF using an isolation approach based on sequential precipitation results in a 100-fold purification, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF include: 1. Terry Phillips at NIH developed an assay that looked promising but after his retirement it has not been possible for other researchers to get this working. 2. Avi Rosenberg, NCI has developed a promising ELISA-style assay, as well as some work in a mass spectrometry assay, and this is being further refined. |
| Secondary | Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange. | End of study | Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification. Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include: 1. Terry Phillips at NIH developed an assay that looked promising prior to his retirement. 2. Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined. |
| Secondary | Correlate the Effect of Immunosuppressive Agents Which Reduce Proteinuria in Recurrent FSGS With the Effect on FPF Levels | End of study | Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification. Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include: 1. Terry Phillips at NIH developed an assay that looked promising prior to his retirement. 2. Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined. |
| Secondary | Determine Whether Renal Transplantation in Patients Whose Elevated FPF Levels Have Been Reduced for a Sustained Period is Associated With a Reduced Prevalence of Recurrent FSGS. | End of study | Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification. Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include: 1. Terry Phillips at NIH developed an assay that looked promising prior to his retirement. 2. Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | every 3 months up to a year followed with native kidneys | all participants, regardless of amount of follow-up | proportion of participants with outcome | MEAN |
| SECONDARY | Comparison of RNA Expression Profiles in PBMC From Patients With FPF, Without FPF and Control Subjects | End of study | Participants with FPF, without FPF and control subjects who have also had RNA expression profiling done in PBMCs. | ||
| SECONDARY | Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange. | End of study | 1- albumin glomerular permeability ratio | MEAN | |
| SECONDARY | Correlate the Effect of Immunosuppressive Agents Which Reduce Proteinuria in Recurrent FSGS With the Effect on FPF Levels | End of study | Participants with FPF levels assayed following immunosuppressive therapies (currently none). Note: its assay had not yet been developed to an extent that it could be applied beyond the provisional values assayed for 3 of the first 4 enrollees using a version implemented by Dr.Virginia Savin, VA Medical Center/Kidney Institute, Kansas City, Missouri | ||
| SECONDARY | Determine Whether Renal Transplantation in Patients Whose Elevated FPF Levels Have Been Reduced for a Sustained Period is Associated With a Reduced Prevalence of Recurrent FSGS. | End of study | Participants whose post-transplantation follow-up yields 1 or more assayed FPF levels |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | A. Complete remission: proteinuria <0.3 g/d | 0 | 95% Confidence Interval 0 to 0.00049 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | A. Complete remission: proteinuria <0.3 g/d | 0 | 95% Confidence Interval 0 to 0.975 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | A. Complete remission: proteinuria <0.3 g/d | 0.5 | 95% Confidence Interval 0.01258 to 0.9874 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | B. Partial remission: proteinuria in [0.3,2] g/d | 0.25 | 95% Confidence Interval 0.05486 to 0.5719 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | B. Partial remission: proteinuria in [0.3,2] g/d | 0 | 95% Confidence Interval 0 to 0.975 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | B. Partial remission: proteinuria in [0.3,2] g/d | 0 | 95% Confidence Interval 0 to 0.8419 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | C. Incomplete response: proteinuria in (2,3.5) g/d | 0 | 95% Confidence Interval 0 to 0 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | C. Incomplete response: proteinuria in (2,3.5) g/d | 0 | 95% Confidence Interval 0 to 0 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | C. Incomplete response: proteinuria in (2,3.5) g/d | 0 | 95% Confidence Interval 0 to 0 | proportion of participants with outcome |
| Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. | FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | D. Relapse: return to proteinuria ≥3.5 g/d | 0.1667 | 95% Confidence Interval 0.02086 to 0.4841 | proportion of participants with outcome |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | 12 | |
| Overall Study | STARTED | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 1 | |
| Overall Study | STARTED | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 2 | |
| Overall Study | STARTED | Historical Controls | 0 | |
| Overall Study | FSGS Permeability Factor (FPF) Assayed | FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | 0 | |
| Overall Study | FSGS Permeability Factor (FPF) Assayed | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 1 | |
| Overall Study | FSGS Permeability Factor (FPF) Assayed | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 2 | |
| Overall Study | FSGS Permeability Factor (FPF) Assayed | Historical Controls | 0 | |
| Overall Study | Initial Transplant | FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | 12 | |
| Overall Study | Initial Transplant | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events12
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 |
|---|---|---|---|---|---|---|
| serious | Rejection of Kidney Graft | Immune system disorders | Plasma Exchange + Cyclophosphamide, Complete Treatment | 1 | 12 | 1 |
| serious | Rejection of Kidney Graft | Immune system disorders | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 0 | 1 | 0 |
| serious | Rejection of Kidney Graft | Immune system disorders | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 0 | 2 | 0 |
| serious | Hemorrhagic cystitis | Infections and infestations | Plasma Exchange + Cyclophosphamide, Complete Treatment | 1 | 12 | 1 |
| serious | Hemorrhagic cystitis | Infections and infestations | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 0 | 1 | 0 |
| serious | Hemorrhagic cystitis | Infections and infestations | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 0 | 2 | 0 |
| serious | Adenocarcinoma of the Prostate Gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Plasma Exchange + Cyclophosphamide, Complete Treatment | 1 | 12 | 1 |
| serious | Adenocarcinoma of the Prostate Gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 0 | 1 | 0 |
| serious | Adenocarcinoma of the Prostate Gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 0 | 2 | 0 |
| serious | Neutropenia | Blood and lymphatic system disorders | Plasma Exchange + Cyclophosphamide, Complete Treatment | 1 | 12 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plasma Exchange + Cyclophosphamide, Complete Treatment | ||
| Total, all-cause mortality | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | ||
| Total, all-cause mortality | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | ||
| Total, other adverse events | Plasma Exchange + Cyclophosphamide, Complete Treatment | 0 | 12 |
| Total, other adverse events | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 0 | 1 |
| Total, other adverse events | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 0 | 2 |
| Total, serious adverse events | Plasma Exchange + Cyclophosphamide, Complete Treatment | 3 | 12 |
| Total, serious adverse events | FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 0 | 1 |
| Total, serious adverse events | FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 0 | 2 |
Source ClinicalTrials.gov
Papers3
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.
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