Effects of Systemic NO-Inhibition on Renal Hemodynamics in NCT00345137

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00345137
Other study ID #	MED.RES.HOS.1995.02.JNB
Secondary ID
Status	Completed
Phase	Phase 1
First received	June 24, 2006
Last updated	June 24, 2006

Study information
Verified date	June 2006
Source	Regional Hospital Holstebro
Contact	n/a
Is FDA regulated	No
Health authority	Denmark: National Board of Health
Study type	Interventional

Clinical Trial Summary

The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.

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 information / eligibility
Status	Completed
Enrollment	75
Est. completion date
Est. primary completion date
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	20 Years to 60 Years
Eligibility	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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Ng-monomethyl-L-arginine (drug)

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Regional Hospital Holstebro

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Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)