Status:
COMPLETED
Kidney Disease Biomarkers
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Kidney Disease
Glomerular Disease
Eligibility:
All Genders
2+ years
Brief Summary
Kidney Disease Biomarkers Summary: This study will identify biomarkers (proteins and other molecules in the blood or urine) that may help scientists predict what kidney disease a patient has and whet...
Detailed Description
There is a pressing need to develop biomarkers for renal disease, which might assist in diagnosis and prognosis and might provide endpoints for clinical trials of drugs designed to slow progression of...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Children with newly diagnosed clinical idiopathic nephrotic syndrome between the ages of 2-18 years.
- Children with previously diagnosed clinical idiopathic nephrotic syndrome between the age of 2-18 years at the time of diagnosis who sustain a relapse of nephrotic syndrome while off steroid therapy. A relapse is defined as a urine protein level of 2+ (100mg/dl) or greater on a first morning urine sample for 3 consecutive days. While a quantitative urine protein/creatinine ratio is more precise, this semi-quantitative definition accords with pediatric practice. Relapses will be treated according to standard clinical practice.
- Children and adults who participate in NIH trials of remittive therapy for MCD/FSGS/CG (e.g. Podocyte dexamethasone or Retinoids for podocyte disease) will be eligible.
- Also, we will study up to 10 healthy adult volunteers.
- EXCLUSION CRITERIA:
- IN CHILDREN, ANY OF THE FOLLOWING
- Age less than 2 years. The rationale for excluding children under the age of 2 yr is that nephrotic syndrome is unusual in this age group and may have etiologies other than MCD and FSGS
- Uncontrolled hypertension (a systolic or diastolic which is greater than 95% population mean for child s age and sex, while receiving therapy), azotemia (serum creatinine greater than 1.5mg/dL), gross hematuria at the time of presentation (clinical markers of primary or secondary GN).
- Hypocomplementemia, positive ANA, anti-DS DNA, ASO, anti-DNase B, MPO, PR-3, Hepatitis B and C and HIV serologies.
- In children or adults:
- Clinical contra-indications to steroid therapy.
- The presence of medical conditions that might interfere with the interpretation of results, such as cancer, diabetes, or a long history of hypertension.
- Healthy adult volunteers:
- age greater than 18 yrs; no history of hypertension, diabetes, or other chronic illness that might complicate interpretation of the results; not taking prescription medication.
- CKD PROGRESSION STUDY:
- INCLUSION CRITERIA:
- Renal biopsy diagnosis of glomerular disease or interstitial nephritis or clinical diagnosis of diabetic nephropathy.
- Mild or moderate renal insufficiency, defined as eGFR less than 60 ml/min/1.73m(2) but greater than 30 ml/min/1.73m(2).
- EXCLUSION CRITERIA:
- 1\) The presence of medical conditions that might interfere with the interpretation of results, such as cancer.
- ANGIOTENSIN ANTAGONISM STUDY:
- INCLUSION CRITERIA:
- Adults greater than 18 years old. Few children have diabetic nephropathy and the frequent blood draws would be problematic for children.
- Type 1 or Type 2 diabetes. Later studies will be expanded to other glomerular diseases.
- Urinary albumin/creatinine ratio greater than 30 mg/g. The rationale is to include patients with macroproteinuria and patients with microalbuminuria.
- Estimated GFR greater than 30 mL/min/1.73m(2). The rationale is to exclude patients with severe CKD.
- EXCLUSION CRITERIA:
- Allergy to ACE inhibitor or ARB
- Current or planned pregnancy; urine HCG performed at start of study and on the day of iothalamate infusion.
- Serum potassium greater than 5.0 mEq/L off angiotensin antagonist therapy
- The presence of medical conditions which would make interpretation of results difficult such as cancer.
- History of iodine allergy or severe asthma (history of emergency department visit or hospitalization).
- SEX DIFFERENCES IN URINARY EXOSOME PROTEINS:
- INCLUSION CRITERIA:
- Age 18-30; Young adults are less likely to have undetected chronic renal disease.
- BMI 18-27.5 kg/m(2); Obesity may alter renal function.
- BP consistently less than 130/80; Pre-hypertension or hypertension may affect the kidney.
- EXCLUSION CRITERIA:
- Any chronic illness that might interfere with interpretation of the study; certain illnesses that do not require therapy may be consistent with inclusion, including mild asthma or psychiatric illness.
- Cancer other than non-melanoma skin cancer in the past 5 years.
- Need for any chronic or intermittent medication other than acetaminophen.
- Women: amenorrhea, irregular menses, menstrual cycles less than 26 days or greater than 32 days, or use of contraceptive hormones (unwilling or unable to switch to non-hormonal means of contraception); Irregular cycle may be non-ovulatory and associated with abnormal sex hormone profiles, which will complicate data interpretation.
- Use of nicotine or illicit drugs.
- Febrile illness or urinary tract infection: postpone admission one week or more.
- SALT INTAKE AND BLOOD PRESSURE RESPONSES IN URINARY EXOSOMES:
- INCLUSION CRITERIA:
- Men Age 18-35
- BMI 18-25 kg/m(2)
- BP consistently less than 130/80
- EXCLUSION CRITERIA:
- Any chronic illness that might interfere with interpretation of the study; certain illnesses that do not require therapy may be consistent with inclusion, including mild asthma or psychiatric illness
- Cancer other than non-melanoma skin cancer in the past 5 years
- Need for any chronic or intermittent medication other than acetaminophen
- Use of nicotine or illicit drug
- Febrile illness or urinary tract infection: postpone admission one week or more
Exclusion
Key Trial Info
Start Date :
November 10 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00255398
Start Date
November 10 2005
End Date
December 3 2014
Last Update
December 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892