Anemia of Chronic Kidney Disease Clinical Trial
Official title:
Effect of Pentoxifylline Administration on Hemoglobin Level of Hemodialysis Patients
Verified date | November 2018 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Our study investigated the effect of using a known drug used in intermittent claudication (named pentoxifylline) as an adjuvant to erythropoietin stimulating agents to improve anemia of hemodialysis patients.
Status | Completed |
Enrollment | 57 |
Est. completion date | May 4, 2018 |
Est. primary completion date | May 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - (Patients with ESRD on HD who have hemoglobin <11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio >65%.). There were 57 patients who met the inclusion criteria out of 158 patients Exclusion Criteria: - Iron deficiency anemia with transferrin saturation <30%, intact PTH>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta university hospital | Tanta |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. — View Citation
Del Vecchio L, Locatelli F. Anemia in chronic kidney disease patients: treatment recommendations and emerging therapies. Expert Rev Hematol. 2014 Aug;7(4):495-506. doi: 10.1586/17474086.2014.941349. Review. — View Citation
González-Espinoza L, Rojas-Campos E, Medina-Pérez M, Peña-Quintero P, Gómez-Navarro B, Cueto-Manzano AM. Pentoxifylline decreases serum levels of tumor necrosis factor alpha, interleukin 6 and C-reactive protein in hemodialysis patients: results of a randomized double-blind, controlled clinical trial. Nephrol Dial Transplant. 2012 May;27(5):2023-8. doi: 10.1093/ndt/gfr579. Epub 2011 Oct 3. — View Citation
Kuragano T, Kitamura K, Matsumura O, Matsuda A, Hara T, Kiyomoto H, Murata T, Fujimoto S, Hase H, Joki N, Fukatsu A, Inoue T, Itakura Y, Nakanishi T. ESA Hyporesponsiveness Is Associated with Adverse Events in Maintenance Hemodialysis (MHD) Patients, But Not with Iron Storage. PLoS One. 2016 Mar 2;11(3):e0147328. doi: 10.1371/journal.pone.0147328. eCollection 2016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hemoglobin difference | the difference in haemoglobin concentration between the pentoxifylline and control group at the end of the 6 months study period. | after 6 months from the start | |
Secondary | difference in inflammatory markers | Difference in CRP and albumin levels between the two groups | after 6 months from the start |
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