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The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.
Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. Therefore, it is necessary to optimize such treatment for further improving renal outcome.
The aim of the present study was to compare the effects of three different types of RAAS blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours proteinuria in patients with non-diabetic chronic kidney disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C - A - B | Active Comparator | (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg |
|
| B - A - C | Active Comparator | (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg |
|
| A - B - C | Active Comparator | (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren, eplerenon, telmisartan | Drug | aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms | changes of UACR | baseline and the end of 8 week treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in transforming growth factor beta (TGF-beta) between treatment arms | Changes of urinary excretion of transforming growth factor beta (TGF-beta) | baseline and the end of 8 week treatments |
| Difference in serum potassium and creatinine between treatment arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bolesław Rutkowski, Professor | Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland | Principal Investigator |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D000077545 | Eplerenone |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| baseline and the end of 8 week treatments |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |