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| Name | Class |
|---|---|
| Bio3 Research s.r.l. - Milan Italy | UNKNOWN |
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Over the last decades, peritoneal dialysis has grown worldwide to become one of the most common modalities of renal replacement therapy, particularly in developing or newly industrialized countries, such as India, China, Korea, Turkey, Malaysia, Mexico and Brazil. Peritoneal dialysis has been associated with an initial survival benefit compared to hemodialysis, although this advantage becomes less apparent over time, likely due to the progressive loss of residual renal function and the development of pathological alterations of peritoneum . Recent results suggest that an antioxidant therapy by N-acetyl-cysteine oral supplementation may improve residual renal function in peritoneal dialysis patients. This finding may have major clinical relevance, as preserving residual renal function in peritoneal dialysis patients has been associated with improved survival . Aim of the present randomized, double-blind, crossover study is to confirm the preliminary evidence of the beneficial effects of antioxidant agents on residual renal function by using the L-enantiomeric form of cysteine in 10 prevalent peritoneal dialysis patients with residual diuresis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-cysteine (Biocysan®) | Experimental | Study subjects will take one tablet of L-cysteine or placebo every morning four times a week and two tablets of L-cysteine or placebo three times a week during the whole study period |
|
| Placebo | Placebo Comparator | Study subjects will take one tablet of L-cysteine or placebo every morning four times a week and two tablets of L-cysteine or placebo three times a week during the whole study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-cysteine | Dietary Supplement |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urine output | Changes from Baseline at 1,2 and 3 month. | |
| Measured Glomerular Filtration Rate (GFR) | Changes from baseline at 1, 2 and 3 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Office systolic, diastolic, pulse and mean blood pressure | Changes from Baseline at 1,2 and 3 month. | |
| Urinary albumin excretion. | Changes from Baseline at 1,2 and 3 month. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center for Rare Diseases | Ranica | Bergamo | 24020 | Italy |
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| ID | Term |
|---|---|
| D014511 | Uremia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003545 | Cysteine |
| ID | Term |
|---|---|
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013438 | Sulfhydryl Compounds |
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| Other |
|
| 2.27% Peritoneal Equilibration test (PET) |
| Changes from Baseline at 1,2 and 3 month. |
| Pulse wave velocity (measured by tonometry) | Changes from Baseline at 1,2 and 3 month. |
| Augmentation Index (measured by tonometry) | Changes from Baseline at 1,2 and 3 month. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D021542 |
| Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |