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View Clinical Trial (Medical Research Study)
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Cause of Focal Segmental Glomerulosclerosis - NCT00001392-20892 (Clinical Trial 111171)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy111171.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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AIDS Associated Nephropathy - Focal Glomerulosclerosis - HIV Infections |
| Purpose: |
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The present protocol seeks to advance our understanding of glomerular diseases characterized
by progressive glomerulosclerosis in the absence of established immune-mediated renal
injury. To this end, we will enroll patients with primary podocytopathies (minimal change
nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy) and diabetic
nephropathy, as well as patients with the clinical diagnosis (prior to renal biopsy) with
one of these conditions. The protocol has three modules, with two consents and two assents.
There is no ceiling on patient recruitment for modules 1 and 2. We want to recruit 16
patients for module 3.
1. EVALUATION AND TREATMENT OF GLOMERULOSCLEROSIS: This protocol will serve as a
screening protocol for specific treatment protocols. It will also allow us to provide
second opinions about selected glomerular diseases, to collect research samples (blood,
urine, and archival kidney tissue) and treat selected patients with renal disease using
standard therapy. These studies will allow us to test particular hypotheses and may
provide the opportunity to generate new hypotheses that could be tested in other
protocols.
2. RESEARCH RENAL BIOPSY IN PATIENTS WITH GLOMERULOSCLEROSIS: We will carry out renal
biopsy for research purposes (limited to previously-diagnosed collapsing
glomerulopathy) or to obtain additional renal tissue for research from a biopsy
performed for clinical indications (includes diagnosed or suspected minimal change
nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy, diffuse
mesangial sclerosis, and diabetic nephropathy). This tissue will be used for studies
of the podocyte transcriptome, and other glomerular and tubular processes, and for
studies to identify viral causes of primary podocyte diseases.
3. Obesity-Associated Kidney Disease. We will collaborate with Dr. Mona Khurana in studies
of lean and obese young adults carried out at Children's National Medical Center. We
will assist her in the measurements of iothalamate and para-aminnohippurate clearance,
in order to determine glomerular filtration rate and renal plasma flow.
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| Study summary: |
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The present protocol seeks to advance our understanding of glomerular diseases characterized
by progressive glomerulosclerosis in the absence of established immune-mediated renal
injury. To this end, we will enroll patients with primary podocytopathies (minimal change
nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy) and diabetic
nephropathy, as well as patients with the clinical diagnosis (prior to renal biopsy) with
one of these conditions. The protocol has three modules, with three consents and three
assents. There is no ceiling on patient recruitment for modules 1 and 2. We want to
recruit 16 patients for module 3.
1. EVALUATION AND TREATMENT OF GLOMERULOSCLEROSIS: This protocol will serve as a
screening protocol for specific treatment protocols. It will also allow us to provide
second opinions about selected glomerular diseases, to collect research samples (blood,
urine, and archival kidney tissue) and treat selected patients with renal disease using
standard therapy. These studies will allow us to test particular hypotheses and may
provide the opportunity to generate new hypotheses that could be tested in other
protocols.
2. RESEARCH RENAL BIOPSY IN PATIENTS WITH GLOMERULOSCLEROSIS: We will carry out renal
biopsy for research purposes (limited to previously-diagnosed collapsing
glomerulopathy) or to obtain additional renal tissue for research from a biopsy
performed for clinical indications (includes diagnosed or suspected minimal change
nephropathy, focal segmental glomerulosclerosis, collapsing glomerulopathy, diffuse
mesangial sclerosis, and diabetic nephropathy). This tissue will be used for studies
of the podocyte transcriptome, and other glomerular and tubular processes, and for
studies to identify viral causes of primary podocyte diseases.
3. OBESITY-ASSOCIATE KIDNEY DISEASE. We will collaborate with Dr. Mona Khurana in studies
of lean and obese young adults carried out at Children's National Medical Center. We
will assist her in the measurements of iothalamate and para-aminnohippurate clearance,
in order to determine glomerular filtration rate and renal plasma flow. |
| Criteria: |
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- Module 1: EVALUATION AND TREATMENT OF GLOMERULOSCLEROSIS
INCLUSION CRITERIA:
Children of all ages and adults, including pregnant women, and impaired subjects, all with
kidney disease. For pathogenetic studies, we will also include healthy volunteers,
including children greater than 12 yrs of age and adults.
EXCLUSION CRITERIA:
None
Module 2: RESEARCH RENAL BIOPSY
1. Clinically-indicated renal biopsy, with use of a portion of a second biopsy core for
research.
INCLUSION CRITERIA:
All adults or children with past renal biopsy which demonstrated a glomerulosclerotic
disease or in all adults or children without prior renal biopsy and clinical
suspicion of glomerulosclerotic disease.
EXCLUSION CRITERIA;
Pregnant women.
2. Clinically-indicated renal biopsy, obtaining a third biopsy core for research
purposes.
INCLUSION CRITERIA:
All adults with past renal biopsy which demonstrated a glomerulosclerotic disease or
in all adult patients without prior renal biopsy and high pre-test likelihood of a
glomerulosclerotic disease.
EXCLUSION CRITERIA:
Pregnant women, patients with a single kidney, impaired subjects, and children less
than 18 yr.
3. Research renal biopsy, performed largely or exclusively for research purposes.
INCLUSION CRITERIA:
Adults with collapsing glomerulopathy.
EXCLUSION CRITERIAN:
Pregnant women, patients with a single kidney, impaired subjects, and children less than
18 yr.
Module 3: RENAL FUNCTION AND STRUCTURE IN LEAN, OVERWEIGHT, AND OBESE YOUNG ADULTS
INCLUSION CRITERIA:
Young adults aged 18 to 21, including lean young adults with BMI less than 25 kg/m2 and
obese young adults with BMI greater than 30 kg/m2. Participants with a history of
hyperlipidemias or high fasting glucose will still be eligible for the study as these
co-morbidities are often consequence of being obese.
EXCLUSION CRITERIA:
Young adults with proteinuria (random urine protein to creatinine ratio greater than 0.2,
microalbuminuria (spot urine albumin to cretinine ratio greater than 20 mg/g), creatinine
clearance less than 80 mL/min/1.73m2, chronic kidney disease, high blood pressure
(systolic blood pressure greater than 140 and diastolic blood pressure greater than 90 on
3 blood pressure readings obtained at least one week apart), diabetes, and pregnant women. |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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