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

Phase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic Glomerulonephritis

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00345137
Enrollment
75
Registered
2006-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2006-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADPKD, Glomerulonephritis

Keywords

Renal hemodynamics, Nitric oxide

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

Interventions

Sponsors

Regional Hospital Holstebro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026