- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345137
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a randomized, placebo controlled design, the effects of systemic treatment with monomethyl-L-arginine are studied on:
- renal hemodynamics
- renal sodium excretion and lithium clearance
- blood pressure and heart rate
- 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
Study Type
Enrollment
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Erling B Pedersen, Professor, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED.RES.HOS.1995.02.JNB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glomerulonephritis
-
Celldex TherapeuticsTerminatedC3 Glomerulonephritis | Dense Deposit Disease | Membranoproliferative Glomerulonephritis Type IIUnited States
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompletedC3 Glomerulopathy | C3 Glomerulonephritis | Dense Deposit Disease | Immune Complex Mediated Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis Types I, II, and IIINetherlands, Australia, Belgium
-
Mario Negri Institute for Pharmacological ResearchAlexion PharmaceuticalsCompletedIC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Dense Deposit Disease | Immune Complex Membranoproliferative GlomerulonephritisItaly
-
University Magna GraeciaCompletedIGA GlomerulonephritisItaly
-
Apellis Pharmaceuticals, Inc.Active, not recruitingC3G | IC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Complement 3 Glomerulopathy | Complement 3 Glomerulopathy (C3G) | Complement 3 Glomerulonephritis | Dense Deposit Disease | DDD | Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis (MPGN) | Immune Complex Membranoproliferative...United States, Spain, France, Germany, United Kingdom, Netherlands, Brazil, Israel, Japan, Australia, Austria, Italy, Switzerland, Korea, Republic of, Czechia, Belgium, Argentina, Canada, Poland
-
Apellis Pharmaceuticals, Inc.Active, not recruitingC3G | IC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Complement 3 Glomerulopathy | Complement 3 Glomerulopathy (C3G) | Complement 3 Glomerulonephritis | Dense Deposit Disease | DDD | Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis (MPGN) | Immune Complex Membranoproliferative...United States, Australia, Brazil, Czechia, France, Italy, Korea, Republic of, Netherlands, Spain, Switzerland, United Kingdom
-
Apellis Pharmaceuticals, Inc.AvailableC3G | IC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Complement 3 Glomerulopathy | Complement 3 Glomerulopathy (C3G) | Complement 3 Glomerulonephritis | Dense Deposit Disease | DDD | Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis (MPGN) | Immune Complex Membranoproliferative...United States
-
Assiut UniversityUnknownMembranoproliferative Glomerulonephritis
-
Mayo ClinicCompletedGlomerulonephritis, MembranoproliferativeUnited States
-
Nagoya UniversityRohto Pharmaceutical Co., Ltd.Completed
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