Influence of Aliskiren on Albuminuria After Kidney Transplantation
Information source: Medical University of Gdansk
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Albuminuria
Intervention: aliskiren (Drug); losartan (Drug); Placebo (Other)
Phase: N/A
Status: Completed
Sponsored by: Medical University of Gdansk Official(s) and/or principal investigator(s): Boleslaw Rutkowski, Prof., Principal Investigator, Affiliation: Deaprtment of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk
Summary
The study is a randomised, double-blind, controlled 2 x 3 cross-over trial in which the
renal effects of therapy with aliskiren (A), placebo (P) and losartan (L) will be compared.
It consists of an 8-week run-in period, 8 weeks of active treatment with aliskiren or
losartan (period 1), 8 weeks of active treatment with the alternative medication (period 2),
and an 8-week placebo administration between them.
Clinical Details
Official title: Influence of Aliskiren on Albuminuria After Kidney Transplantation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: a difference in albuminuria in the measurements available for each patient
Secondary outcome: a differences in N-acetyl-β-D-glucosaminidase (NAG) urine excretion in the measurements available for each patienta differences in transforming growth factor β-1 (TGF-β-1) urine excretion in the measurements available for each patient a differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient
Detailed description:
At the beginning, subjects who met the inclusion criteria will enter the 8-week run-in
screening period. All hypotensive group of drugs will be allowed with exception of ACEI,
ARA, DRI and mineralocorticoid receptor antagonists. The target BP will be an office trough
BP of 140/90 mmHg or less. At the end of the run-in period, patients will be randomly
allocated to one of the two treatment sequences: L/P/A (sequence 1) or A/P/L (sequence 2) .
The study medications will be introduced as single hypotensive drug or added to the current
hypotensive agents, the dosage of which, once adjusted in the run-in period, will be left
unchanged throughout the study. Losartan will be used at a dose of 50 mg and aliskiren will
be administered at a dose of 150 mg. Drug compliance will be assessed by tablet counts.
Patients will be recommended not to change their usual daily protein and sodium intake
during the study period. Dosage of cyclosporine or tacrolimus will be not allowed to change
either. At the end of each of the three treatment periods, office thorough BP, 24-h
ambulatory BP, albuminuria, serum creatinine and potassium, haemoglobin, cyclosporine or
tacrolimus level, urine excretion of NAG, TGF-β-1 and 15-F2t-isoprostanes will be
determined. eGFR will be calculated. Patients will be also asked to fill in the
questionnaire for measuring patients-reported side effects.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Transplantation period above 6 months,
2. Calcineurin inhibitor (cyclosporine or tacrolimus) based immunosuppression,
3. Stable cyclosporine or tacrolimus trough level in the last three months (no
variations above 25%),
4. Stable renal function defined as eGFR > 30 ml/min (no variations above 5 ml/min/1. 73
m2 in the last 3 months),
5. Arterial hypertension treated with one or two antihypertensive agents or blood
pressure (BP) > 130/80 mmHg in patients not treated yet,
6. Albuminuria > 30 mg/g creatinine.
Exclusion Criteria:
1. Pregnant or the possibility of becoming so and breast feeding.
2. Angioedema from an ACE inhibitor or ARA in the history.
3. Serum potassium greater than 5. 5 mmol/l on two or more occasions in the preceding
three months.
4. Graft artery stenosis (i. e. psv of more than 200 cm/s in doppler usg)
5. Left ventricular dysfunction that requires an ACE inhibitor or an ARA Protocol
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6. New immunosuppressive agent was started or previous immunosuppressant stopped in the
three months prior to study entry or plan to switch immunosuppressive agents within
next three months.
7. Currently on four or more blood pressure pills and have an average blood pressure
over three visits greater than 150/100.
8. Currently on an ACE-inhibitor or an ARAor treatment with an ACE inhibitor or ARA
after kidney transplantation lasted more than 3 months.
9. Had an acute coronary syndrome, episode of malignant hypertension, stroke or
transient ischaemic attack in the three months prior to study entry
Locations and Contacts
Medical University of Gdansk, Gdansk, Pomorskie 80-211, Poland
Additional Information
Starting date: March 2013
Last updated: May 13, 2015
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