Back to resultsInfluence of Aliskiren on Albuminuria After Kidney Transplantation
Primary Purpose
Albuminuria
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
aliskiren
losartan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Albuminuria focused on measuring direct renin inhibitor, kidney transplantation, albuminuria
Eligibility Criteria
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
Sites / Locations
- Medical University of Gdansk
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
aliskiren - placebo - losartan
losartan - placebo - aliskiren
Arm Description
aliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
aliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
Outcomes
Primary Outcome Measures
a difference in albuminuria in the measurements available for each patient
Secondary Outcome Measures
a differences in N-acetyl-β-D-glucosaminidase (NAG) urine excretion in the measurements available for each patient
a 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02446548
Brief Title
Influence of Aliskiren on Albuminuria After Kidney Transplantation
Official Title
Influence of Aliskiren on Albuminuria After Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albuminuria
Keywords
direct renin inhibitor, kidney transplantation, albuminuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aliskiren - placebo - losartan
Arm Type
Experimental
Arm Description
aliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
Arm Title
losartan - placebo - aliskiren
Arm Type
Experimental
Arm Description
aliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
Intervention Type
Drug
Intervention Name(s)
aliskiren
Other Intervention Name(s)
Rasilez (Novarits Europe)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
losartan
Other Intervention Name(s)
Xartan (Adamed, Poland)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
a difference in albuminuria in the measurements available for each patient
Time Frame
after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
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
Title
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
Title
a differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient
Time Frame
after 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boleslaw Rutkowski, Prof.
Organizational Affiliation
Deaprtment of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Gdansk
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-211
Country
Poland
12. IPD Sharing Statement
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Influence of Aliskiren on Albuminuria After Kidney Transplantation
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