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| Name | Class |
|---|---|
| Cell Therapy And Technology, S.a. De C.v. | INDUSTRY |
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The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone | Experimental | Pirfenidone 1200 mg in the form of prolonged-released tablets, orally administered two times a day (b.i.d.) to yield a daily dose of 2400 mg during three years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | Pirfenidone was supplied orally in the form of prolonged-released tablets according with body surface area (m2 BS) of each patient. The target dosage of PFD was 1200 mg two times a day (b.i.d.) for a full dosage of 2400 mg daily during three years. Therapy was initiated at 600 mg b.i.d. and escalated to full dosage after 3 weeks when symptoms were controlled. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease. | The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO. | three years |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the use of Pirfenidone in renal function | The renal function was monitored by cystatin C, reciprocal of serum creatinine and creatinine clearance collection of 24 hrs. | Three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Armendariz-Borunda, Ph.D. | Head, Molecular Biology and Genomics Department, University of Guadalajara | Study Director |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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|
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| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |