Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007475
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2000-12-22
Brief Title:
Permeability Factor in Focal Segmental Glomerulosclerosis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Permeability Factor in Focal Segmental Glomerulosclerosis
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Focal segmental glomerulosclerosis FSGS is a renal syndrome characterized by proteinuria usually nephrotic range limited response to conventional therapy and a poor renal prognosis with progression to end stage renal failure in at least 50 of patients As a syndrome FSGS likely has many specific etiologies only a few of which are well-defined Recently it has been suggested that some idiopathic FSGS patients have elevated circulating levels of a protein that induces glomerular permeability in vitro and in vivo While there has been no consistent term for this factor it will be termed here FSGS permeability factor FPF
The purposes of the present study are five fold
1 To identify a population of FSGS patients with elevated FPF levels
2 To examine RNA expression profiles of peripheral blood mononuclear cells PBMC in FSGS patients with elevated FPF levels
3 To define the kinetics of FPF disappearance and reappearance in FSGS patients receiving immunomodulatory therapy and in the case of patients with recurrent FSGS following renal transplant those receiving plasma exchange
4 To identify immunosuppressive agents which are successful in inducing sustained reduction in FPF levels
5 To determine in patients with FSGS who are awaiting renal transplant whether sustained reduction in FPF levels is associated with reduced risk of recurrent FSGS
Patient participation is divided into an evaluation phase in which FPF levels RNA expression profiles and patient eligibility for participation in treatment protocols are determined and a treatment phase in which specific immunomodulatory therapy is introduced in an open label fashion We propose to define carefully the relationship between elevated FPF and remission of proteinuria in patients with FSGS in native kidneys following treatment with standard therapies daily prednisone cyclophosphamide and experimental therapies pulse dexamethasone pirfenidone In patients with recurrent FSGS in renal allografts we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide In patients with elevated FPF levels who are awaiting renal transplantation we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide and examine the rate of recurrent FSGS in these patients
The purposes of the present study are five fold
1 To identify a population of FSGS patients with elevated FPF levels
2 To examine RNA expression profiles of peripheral blood mononuclear cells PBMC in FSGS patients with elevated FPF levels
3 To define the kinetics of FPF disappearance and reappearance in FSGS patients receiving immunomodulatory therapy and in the case of patients with recurrent FSGS following renal transplant those receiving plasma exchange
4 To identify immunosuppressive agents which are successful in inducing sustained reduction in FPF levels
5 To determine in patients with FSGS who are awaiting renal transplant whether sustained reduction in FPF levels is associated with reduced risk of recurrent FSGS
Patient participation is divided into an evaluation phase in which FPF levels RNA expression profiles and patient eligibility for participation in treatment protocols are determined and a treatment phase in which specific immunomodulatory therapy is introduced in an open label fashion We propose to define carefully the relationship between elevated FPF and remission of proteinuria in patients with FSGS in native kidneys following treatment with standard therapies daily prednisone cyclophosphamide and experimental therapies pulse dexamethasone pirfenidone In patients with recurrent FSGS in renal allografts we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide In patients with elevated FPF levels who are awaiting renal transplantation we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide and examine the rate of recurrent FSGS in these patients
Detailed Description:
Focal segmental glomerulosclerosis FSGS is a renal syndrome characterized by proteinuria usually nephrotic range limited response to conventional therapy and a poor renal prognosis with progression to end stage renal failure in at least 50 of patients As a syndrome FSGS likely has many specific etiologies only a few of which are well-defined Recently it has been suggested that some idiopathic FSGS patients have elevated circulating levels of a protein that induces glomerular permeability in vitro and in vivo While there has been no consistent term for this factor it will be termed here FSGS permeability factor FPF
The purposes of the present study are five fold
1 To identify a population of FSGS patients with elevated FPF levels
2 To examine RNA expression profiles of peripheral blood mononuclear cells PBMC
in FSGS patients with elevated FPF levels
3 To define the kinetics of FPF disappearance and reappearance in FSGS patients
receiving immunomodulatory therapy and in the case of patients with recurrent FSGS
following renal transplant those receiving plasma exchange
4 To identify immunosuppressive agents which are successful in inducing sustained
reduction in FPF levels
5 To determine in patients with FSGS who are awaiting renal transplant whether
sustained reduction in FPF levels is associated with reduced risk of recurrent FSGS
Patient participation is divided into an evaluation phase in which FPF levels RNA expression profiles and patient eligibility for participation in treatment protocols are determined and a treatment phase in which specific immunomodulatory therapy is introduced in an open label fashion We propose to define carefully the relationship between elevated FPF and remission of proteinuria in patients with FSGS in native kidneys following treatment with standard therapies daily prednisone cyclophosphamide and experimental therapies pulse dexamethasone pirfenidone In patients with recurrent FSGS in renal allografts we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide In patients with elevated FPF levels who are awaiting renal transplantation we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide and examine the rate of recurrent FSGS in these
patients
The purposes of the present study are five fold
1 To identify a population of FSGS patients with elevated FPF levels
2 To examine RNA expression profiles of peripheral blood mononuclear cells PBMC
in FSGS patients with elevated FPF levels
3 To define the kinetics of FPF disappearance and reappearance in FSGS patients
receiving immunomodulatory therapy and in the case of patients with recurrent FSGS
following renal transplant those receiving plasma exchange
4 To identify immunosuppressive agents which are successful in inducing sustained
reduction in FPF levels
5 To determine in patients with FSGS who are awaiting renal transplant whether
sustained reduction in FPF levels is associated with reduced risk of recurrent FSGS
Patient participation is divided into an evaluation phase in which FPF levels RNA expression profiles and patient eligibility for participation in treatment protocols are determined and a treatment phase in which specific immunomodulatory therapy is introduced in an open label fashion We propose to define carefully the relationship between elevated FPF and remission of proteinuria in patients with FSGS in native kidneys following treatment with standard therapies daily prednisone cyclophosphamide and experimental therapies pulse dexamethasone pirfenidone In patients with recurrent FSGS in renal allografts we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide In patients with elevated FPF levels who are awaiting renal transplantation we will determine the kinetics of FPF following plasma exchange and following plasma exchange plus cyclophosphamide and examine the rate of recurrent FSGS in these
patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-DK-0053 | OTHER | National Institutes of Health | None |