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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 May 2015 |
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Main ID: |
NCT02446548 |
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Date of registration:
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08/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Influence of Aliskiren on Albuminuria After Kidney Transplantation
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Scientific title:
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Influence of Aliskiren on Albuminuria After Kidney Transplantation |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02446548 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Boleslaw Rutkowski, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deaprtment of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk |
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Key inclusion & exclusion criteria
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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
Version 1 p. 5 of 10
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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Albuminuria
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Intervention(s)
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Other: Placebo
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Drug: aliskiren
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Drug: losartan
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Primary Outcome(s)
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a difference in albuminuria in the measurements available for each patient
[Time Frame: after 8 weeks of treatment]
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Secondary Outcome(s)
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a differences in transforming growth factor ß-1 (TGF-ß-1) urine excretion in the measurements available for each patient
[Time Frame: after 8 weeks of treatment]
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a differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient
[Time Frame: after 8 weeks of treatment]
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a differences in N-acetyl-ß-D-glucosaminidase (NAG) urine excretion in the measurements available for each patient
[Time Frame: after 8 weeks of treatment]
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Secondary ID(s)
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ST-4/Aliskiren/KTx
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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