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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00007475
Date of registration: 22/12/2000
Prospective Registration: No
Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Public title: Permeability Factor in Focal Segmental Glomerulosclerosis
Scientific title: Permeability Factor in Focal Segmental Glomerulosclerosis
Date of first enrolment: December 2000
Target sample size: 15
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00007475
Study type:  Interventional
Study design:   
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     Jeffrey B Kopp, M.D.
Address: 
Telephone:
Email:
Affiliation:  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

1. Patients with idiopathic focal segmental glomerulosclerosis on renal biopsy,
including the following categories:

A) Untreated FSGS

B) Steroid-dependent FSGS

C) Steroid resistant FSGS

D) Recurrent FSGS, with functioning allograft

E) FSGS in ESRD, receiving hemodialysis

2. Adults greater than or equal to18 will be eligible for all studies.

3. Children greater than 20 kilograms, will be eligible for all branches of the
study except for treatment of steroid resistant FSGS with pirfenidone, as
pirfenidone has not previously been administered to pediatric patients in any
setting. Children less than 20 kilograms will be excluded from the study for the
following reason: plasma exchange in patients less than 20 kilograms requires a
red blood cell transfusion, which significantly increases the risk of the
procedure by exposing the patient to the risk of transfusion associated
infections, and the safety of an aggressive course of plasma exchange has not
been established in this population.

EXCLUSION CRITERIA:

1. Secondary FSGS: HIV-associated FSGS or hyperfiltration FSGS, including FSGS associated
with congenital renal abnormalities, renal mass reduction, reflux nephropathy,
interstitial nephritis, and sickle cell anemia are excluded.

2. Patients with disease associated with immunosuppression, other than chronic renal
failure.

3. The presence of malignancy or the history of other serious, complicating illness such
as myocardial infarction or cerebrovascular accident in the past six months, at the
discretion of the investigators.

4. For plasma exchange: A Department of Transfusion Medicine consultant will evaluate all
potential plasma exchange patients. Those with prolonged PT, PTT, platelet count less
than 100,000 or receiving anticoagulant therapy will undergo plasma exchange only if
the consultant considers this to be safe.

5. For prednisone: uncontrolled diabetes mellitus (requiring greater than 100 units of
insulin/day with the concurrence of the Endocrinology consultant), active infection
including hepatitis B or C (if that is the advice of the Hepatology consultant),
infection with HIV (as these patients are at increased risk of avascular necrosis),
other active infection (if that is the advice of the Infectious Disease consultant),
history of avascular necrosis or bone densitometry indicating bone mass less than 2SD
below normal, active ulcer disease, history of steroid-induced psychosis, morbid
obesity, positive PPD or history of past positive PPD without adequate treatment are
excluded.

6. For Cyclophosphamide:

A) Allergy or hypersensitivity to cyclophosphamide

B) Leukocyte less than 3000 cells/microliter or ANC less than 1500 cells/microliter or
evidence of bone marrow compromise

C) Prior irradiation to the heart or therapy with doxorubicin or other cardiotoxic
medication (may increase the risk for cardiotoxicity)

D) Peritoneal dialysis, as there is no published evidence that cyclophosphamide metabolites
can be safely removed.

E) Certain drugs will be used with caution or avoided. Barbiturates and phenytoin induce
the hepatic enzymes that metabolize cyclophosphamide and therefore if these medications are
required, cyclophosphamide doses may need to be increased to achieve a comparable
immunosuppressive effect. Drugs that inhibit cyclophosphamide metabolism include
allopurinol, imipramine, and phenothiazines, chloramphenicol and chlorpromazine; these
drugs will be avoided. NSAID increase the risk of hyponatremia; these drugs will be
avoided.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Focal Segmental Glomerulosclerosis
Intervention(s)
Drug: Cyclophosphamide
Procedure: Plasma exchange
Primary Outcome(s)
Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. [Time Frame: every 3 months up to a year followed with native kidneys]
Secondary Outcome(s)
Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange. [Time Frame: End of study]
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. [Time Frame: End of study]
Correlate the Effect of Immunosuppressive Agents Which Reduce Proteinuria in Recurrent FSGS With the Effect on FPF Levels [Time Frame: End of study]
Comparison of RNA Expression Profiles in PBMC From Patients With FPF, Without FPF and Control Subjects [Time Frame: End of study]
Secondary ID(s)
010053
01-DK-0053
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 10/02/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00007475
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