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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00345137
Date of registration:	24/06/2006
Prospective Registration:	No
Primary sponsor:	Regional Hospital Holstebro
Public title:	Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis
Scientific title:	Phase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic Glomerulonephritis
Date of first enrolment:	May 2006
Target sample size:	75
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00345137
Study type:	Interventional
Study design:	Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind
Phase:	Phase 1

Countries of recruitment

Contacts

Name:	Erling B Pedersen, Professor
Address:
Telephone:
Email:
Affiliation:	Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark

Name:	Jesper N Bech, MD, Ph.d.
Address:
Telephone:
Email:
Affiliation:	Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark

Key inclusion & exclusion criteria

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

Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

ADPKD

Glomerulonephritis

Intervention(s)

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

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

MED.RES.HOS.1995.02.JNB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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