No registrations found.
ID
Source
Brief title
Health condition
proteinuria
proteinurie
albuminuria
albuminurie
chronic kidney disease
chronisch nierfalen
non-diabetic renal disease
niet-diabetische nierziekte
paricalcitol
zemplar
vitamin D receptor activator
vitamine D receptor activator
vitamin D
vitamine D
Sponsors and support
Study medication provided by Abbott Inc.
Intervention
Outcome measures
Primary outcome
Albuminuria (24-hour urinary albumin excretion).
Secondary outcome
1. Mean arterial pressure (MAP);
2. Serum creatinine / creatinine clearance;
3. Plasma renin activity (PRA);
4. Renal hemodynamics (measured GFR, ERPF).
Background summary
The primary objective of the VIRTUE tudy is to determine the antialbuminuric response of vitamin D analogue in addition to ACE-inhibitor and low-sodium diet, in renal patients.
Study objective
Prevention of progressive renal function loss remains the main challenge in clinical nephrology. Blockade of the rennin-angiontensin-aldosterone system (RAAS), which can be potentiated by a low sodium diet, is the therapy of choice, but still many patients develop end-stage renal disease on the long term. Recent studies underline a crucial role for the vitamin D pathway in progressive renal function loss, possibly due to interference in the RAAS. We hypothesize that vitamin D (i.e. vitamin D receptor activator; paricalcitol) is able to blunt the reactive rise of renin levels seen in response to RAAS blockade, thus optimizing renoprotection.
Study design
Every 8 weeks.
Intervention
The study question will be addressed in a prospective, multiple-center, double-blind, crossover, randomized placebo-controlled clinical trial. Patients are consecutively treated during eight weeks with placebo or vitamin D analogue, respectively. At the same time, patients will be randomly assigned to either a liberal-sodium diet or a low-sodium diet. All patients receive a standardised dose of ramipril throughout the study.
A.J. Kwakernaak
Department of Medicine, Division of Nephrology, University Medical Center Groningen (UMCG)
“De Brug”, room 4.045
Groningen 9700 RB
The Netherlands
+31 (0)50 3611564
a.kwakernaak@int.umcg.nl
A.J. Kwakernaak
Department of Medicine, Division of Nephrology, University Medical Center Groningen (UMCG)
“De Brug”, room 4.045
Groningen 9700 RB
The Netherlands
+31 (0)50 3611564
a.kwakernaak@int.umcg.nl
Inclusion criteria
1. Male and female patients;
2. Non-diabetic renal disease as established by history, serum biochemistry tests and/or renal biopsy;
3. Age >18 years;
4. Residual proteinuria >300 mg/day and <10 g/day during conventional treatment of at least 8 weeks with ACE-inhibitor or ARB at the maximum recommended dose;
5. Stable renal function (creatinine clearance > 30 ml/min/1.73m2; with < 6 ml/min per year decline);
6. Average of 2 consecutive PTH values of <8.7 pMol/L, 2 consecutive serum calcium levels between 2.0 and 2.6 mmol/l (corrected for albumin levels), 2 consecutive serum phosphorus levels of 1.5 mmol/l within 4 weeks prior to treatment;
7. Written informed consent.
Exclusion criteria
1. Uncontrolled hypertension, hyperkalemia (potassium >6.0 mmol/l, cardiovascular disease (myocardial infarction, unstable angina, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, or stroke within last 6 months, heart failure NYHA III-IV), Diabetes Mellitus;
2. Epilepsy;
3. Liver disease resulting in aberrations of liver function tests;
4. Previously treated (within 3 months of screening) with paricalcitol or vitamin D (analogue);
5. Contraindication to ACEi, high/low-sodium diet or paricalcitol;
6. Medication interacting with ACEi or paricalcitol;
7. Frequent NSAID use (>2 doses/week);
8. Use of immunosuppressive drugs;
9. Use of digoxine;
10. Active malignancy;
11. Any bowel disorder resulting in fat malabsorption;
12. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive ß-hCG laboratory test (>5 mIU/ml);
13. Incompliance with diet or study medication;
14. Any psychiatric condition or psychofarmacon use;
15. Drug or alcohol abuse.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2759 |
| NTR-old | NTR2898 |
| Other | METC UMCG / CCMO : 2009.272 / NL29900.042.09; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |