Condition category
Urological and Genital Diseases
Date applied
29/06/2006
Date assigned
29/06/2006
Last edited
29/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F. Waanders

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
Department of Nephrology
Hanzeplein 1
Groningen
9700 RB
Netherlands
+31 (0)50 3611564
F.Waanders@int.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DUAAAL

Study hypothesis

The recently found gene-environment interaction between dietary sodium intake and the angiotensin-converting enzyme (ACE) genotype with sodium-induced therapy resistance to ACE inhibition in DD homozygotes (that was absent in II and ID subjects) is present in renal patients as well. With regards to the pathophysiological mechanism, we hypothesise that a high dietary sodium intake induces an increase in tissue ACE activity, which is stronger in the DD homozygotes, resulting in a worse therapy response to angiotensin-converting enzyme-inhibitors (ACEi). The alleged sodium-induced therapy resistance of the DD homozygotes may therefore be overcome by addition of angiotensin receptor type 1 (AT1) receptor blockade, since AT1 receptor blockers act downstream of the ACE.
Moreover, we hypothesize that low dietary sodium intake has additional effects on proteinuria and blood pressure on top of dual renin-angiotensin system (RAS) blockade in patients with non-diabetic proteinuria

Ethics approval

Not provided at time of registration

Study design

Randomized, crossover, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Proteinuria

Intervention

Lisinopril 40 mg, with the addition of valsartan 320 mg (160 mg; twice a day) or placebo, both during low dietary sodium intake and high dietary sodium intake in randomised order

Intervention type

Drug

Phase

Not Specified

Drug names

Lisinopril, valsartan

Primary outcome measures

The primary endpoint will be reduction of proteinuria and blood pressure expressed as percentage change from baseline and analysed with each patient as his or her own control

Secondary outcome measures

1. Serum creatinine
2. Circulating RAS parameters
3. Lipid profile
4. Adiponectin

Overall trial start date

28/04/2006

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Older than 18 years of age
2. Chronic non-diabetic renal disease, as established by history, urine analysis, serum biochemistry tests and/or renal biopsy
3. Creatinine clearance >30 ml/min/1.73 m
4. Residual proteinuria >1 g per 24 hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56

Participant exclusion criteria

1. Failure to meet the above inclusion criteria
2. Diabetes mellitus
3. Any contra-indication to the use of ACE inhibitors or AT1 receptor blockers
4. A history of myocardial infarction, unstable angina, coronary bypass or cardiovascular accident (CVA) during the past six months
5. Heart failure New York Heath Association (NYHA) class III-IV
6. High rate of renal function loss (decline in creatinine clearance >6 ml/min/1.73 m^2 during the past year)
7. Need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) or immunosuppressive drugs
8. Proteinuria >10 g per 24 hours and hypoalbuminaemia <28 g/l
9. Renovascular hypertension, malignant hypertension (diastolic blood pressure >100 mmHg)
10. Serum potassium >6 mmol/l

Recruitment start date

28/04/2006

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Novartis Pharma B.V.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes