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van CCT (UK)

van CCT (UK)

Additief antiproteinurisch effect van de vitamine D analoog paricalcitol.

- candidate number9426
- NTR NumberNTR2898
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mei-2011
- Secondary IDs2009.272 / NL29900.042.09; METC UMCG / CCMO
- Public TitleAdditief antiproteinurisch effect van de vitamine D analoog paricalcitol.
- Scientific TitleVitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin.
- hypothesisPrevention 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.
- Healt Condition(s) or Problem(s) studiedProteinuria , Chronic renal failure, Vitamin D, Paricalcitol, Albuminuria, Non-diabetic renal disease, Vitamin D receptor activator
- Inclusion criteria1. 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 criteria1. 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 -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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-jan-2014
- Target number of participants50
- InterventionsThe 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.
- Primary outcomeAlbuminuria (24-hour urinary albumin excretion).
- Secondary outcome1. Mean arterial pressure (MAP);
2. Serum creatinine / creatinine clearance;
3. Plasma renin activity (PRA);
4. Renal hemodynamics (measured GFR, ERPF).
- TimepointsEvery 8 weeks.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Kidney Foundation (Nierstichting Nederland), University Medical Center Groningen (UMCG), Abbott
- PublicationsPublication policy is in agreement with the CCMO publication statement. Nor the sponsors, nor the principal investigator has a right of veto regarding the way of publishing the results.
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD11-mei-2011 - 24-mei-2011

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