Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis
Phase 1
Completed
- Conditions
- ADPKDGlomerulonephritis
- Registration Number
- NCT00345137
- Lead Sponsor
- Regional Hospital Holstebro
- Brief Summary
The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.
- Detailed Description
In a randomized, placebo controlled design, the effects of systemic treatment with monomethyl-L-arginine are studied on:
1. renal hemodynamics
2. renal sodium excretion and lithium clearance
3. blood pressure and heart rate
4. plasma levels of vasoactive hormones
in patients with adult polycystic kidney disease and chronic glomerulonephrits. The results are compared with a group of healthy control subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Healthy controls
- Age 20 to 60 years
- Both men and women
- Weight below 100 kg
- Normal clinical examination and laboratory screening
- Fertile women only if using contraception
- Informed consent according to the regulations of the local etics committee
Chronic glomerulonephritis
- Biopsy veryfied chronic glomerulonephritis
- P-creatinine < 250 µmol/L
- Weight below 100 kg
- Age 20 to 60 years
- Both men and women
- Informed consent according to the regulations of the local etics committee
Adult polycystic kidney disease (APKD)
- Diagnosis of APKD by family history and renal ultrasound or renal angiography
- P-creatinine < 250 µmol/L
- Weight below 100 kg
- Age 20 to 60 years
- Both men and women
- Informed consent according to the regulations of the local etics committee
Exclusion Criteria
Healthy controls
- History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
- Current medication
- Drugs or alcohol abuse
- Pregnancy
- Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
- Donation of blood less than 1 month before the experiments
Chronic glomerulonephritis
- Apart from chronic glomerulonephritis and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
- Patients with nephrotic syndrome or secondary glomerulonephritis
- Current medication other than antihypertensive therapy
- Drugs or alcohol abuse
- Pregnancy
- Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
Adult polycystic kidney disease
- Apart from APKD and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
- Current medication other than antihypertensive therapy
- Drugs or alcohol abuse
- Pregnancy
- Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method