- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446548
Influence of Aliskiren on Albuminuria After Kidney Transplantation
May 13, 2015 updated by: Leszek Tylicki, Medical University of Gdansk
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pomorskie
-
Gdansk, Pomorskie, Poland, 80-211
- Medical University of Gdansk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Transplantation period above 6 months,
- Calcineurin inhibitor (cyclosporine or tacrolimus) based immunosuppression,
- Stable cyclosporine or tacrolimus trough level in the last three months (no variations above 25%),
- Stable renal function defined as eGFR > 30 ml/min (no variations above 5 ml/min/1.73 m2 in the last 3 months),
- Arterial hypertension treated with one or two antihypertensive agents or blood pressure (BP) > 130/80 mmHg in patients not treated yet,
- Albuminuria > 30 mg/g creatinine.
Exclusion Criteria:
- Pregnant or the possibility of becoming so and breast feeding.
- Angioedema from an ACE inhibitor or ARA in the history.
- Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months.
- Graft artery stenosis (i.e. psv of more than 200 cm/s in doppler usg)
- Left ventricular dysfunction that requires an ACE inhibitor or an ARA Protocol Version 1 p. 5 of 10
- 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.
- Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/100.
- Currently on an ACE-inhibitor or an ARAor treatment with an ACE inhibitor or ARA after kidney transplantation lasted more than 3 months.
- Had an acute coronary syndrome, episode of malignant hypertension, stroke or transient ischaemic attack in the three months prior to study entry
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aliskiren - placebo - losartan
aliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
|
aliskiren will be administered at a dose of 150 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M., except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Drug compliance will be assessed by tablet counts.
Other Names:
losartan will be administered at a dose of 50 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Drug compliance will be assessed by tablet counts.
Other Names:
placebo will be administered once daily orally (1 tablet) in the morning with water at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Compliance will be assessed by tablet counts.
Placebo was prapared in Department of Pharmaceutical Technology MU Gdańsk
|
Experimental: losartan - placebo - aliskiren
aliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
|
aliskiren will be administered at a dose of 150 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M., except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Drug compliance will be assessed by tablet counts.
Other Names:
losartan will be administered at a dose of 50 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Drug compliance will be assessed by tablet counts.
Other Names:
placebo will be administered once daily orally (1 tablet) in the morning with water at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Compliance will be assessed by tablet counts.
Placebo was prapared in Department of Pharmaceutical Technology MU Gdańsk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
a difference in albuminuria in the measurements available for each patient
Time Frame: after 8 weeks of treatment
|
after 8 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
a differences in N-acetyl-β-D-glucosaminidase (NAG) urine excretion in the measurements available for each patient
Time Frame: after 8 weeks of treatment
|
after 8 weeks of treatment
|
a differences in transforming growth factor β-1 (TGF-β-1) urine excretion in the measurements available for each patient
Time Frame: after 8 weeks of treatment
|
after 8 weeks of treatment
|
a differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient
Time Frame: after 8 weeks of treatment
|
after 8 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Boleslaw Rutkowski, Prof., Deaprtment of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
May 8, 2015
First Submitted That Met QC Criteria
May 13, 2015
First Posted (Estimate)
May 18, 2015
Study Record Updates
Last Update Posted (Estimate)
May 18, 2015
Last Update Submitted That Met QC Criteria
May 13, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST-4/Aliskiren/KTx
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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