The Effect on Vascular Reactivity Using the Erythropoeitin Alpha on Incident Peritoneal Dialysis Patients

NCT03286712 | Completed Phase 4 DMC

• 2 other identifiers: NKTIPhilippinesDepartment of Adult Nephrology
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational study on incident peritoneal dialysis patients on the effect of hemoglobin level and vascular reactivity using the generic erythropoietin alpha. The objective of the study is to to describe the effect of improvement in hemoglobin level and the flow-mediated dilatation using Epoeitin Alpha (Renogen). Patients who will meet the inclusion and exclusion criteria will have their baseline laboratory test and ultrasound of the brachial artery to assess the flow mediated dilatation. This is a 3-month follow up study with a monthly laboratory test to monitor the patients. The following are the outcome measures: hemoglobin level, vascular reactivity by measuring the flow mediated dilatation of the brachial artery and blood pressure.

Conditions

Chronic Kidney Disease; Anemia; Complication of Peritoneal Dialysis

Keywords

Flow mediated dilatation; Brachial artery; Anemia; Chronic kidney disease; Renogen; Erythropoietin Alpha

Outcome Measures

Primary Outcomes (1)

• The effect of correction of anemia on the flow mediated-dilatation of the brachial artery

  We will measure the baseline hemoglobin level and the status of the flow mediated-dilatation of the brachial artery. We will assess the status of hemoglobin level and the flow mediated dilatation at the end of the study and show assess its correlation.

  3 months

Secondary Outcomes (2)

• The effect of generic erythropoietin alpha (Renogen) on the hemoglobin level

  3 months

• The effect of Epoietin alpha on blood pressure

  3 months

Study Arms (1)

Incident Peritoneal Dialysis

EXPERIMENTAL

After signing informed consent form, the patients will be started on Renogen® at 150 units/kg/week. Oral iron supplements will be started at 105 mg elemental iron per day. If the patients will not have an increase in Hb by 1-2 g/dl or an increase in the reticulocyte count after the first month of treatment, the dose of Renogen® will be increased to 200 units/kg/week. If there will still be no increase in the Hb or reticulocyte count in the second month, other causes of anemia will be ruled out. If the Hb/Hct will increase beyond the target, the Renogen® dose will be reduced by 50 units/kg/week. If the Hb/Hct will be below target, the Renogen® dose will be increased by 50 units/kg/week.

Drug: Renogen

Interventions

Renogen DRUG

Administration of erythropietin alpha to see the effect on the hemoglobin level and vascular reactivity

Also known as: Epoietin Alpha

Incident Peritoneal Dialysis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 60 years old
• Newly diagnosed ESRD patients started on peritoneal dialysis for less than 3 months not previously on any type of EPO. If previously on a different brand of EPO, patient will have a washout period of 4 weeks.
• Can follow up at NKTI OPD for at least 3 months
• Can take oral iron supplements

You may not qualify if:

• Known allergy to EPO
• With severe illness such as congestive heart failure Class III - IV, acute myocardial infarction, infection within 1 month of starting the study or had a severe hepatic disease.

Sponsors & Collaborators

• National Kidney and Transplant Institute, Philippines: lead

Study Sites (1)

Department of Adult Nephrology; National Kidney and Transplant Institute

Quezon City, National Capital Region, 1101, Philippines

Location

Related Publications (11)

• Obrador GT, Roberts T, St Peter WL, Frazier E, Pereira BJ, Collins AJ. Trends in anemia at initiation of dialysis in the United States. Kidney Int. 2001 Nov;60(5):1875-84. doi: 10.1046/j.1523-1755.2001.00002.x.

  PMID: 11703606 BACKGROUND

• Revicki DA, Brown RE, Feeny DH, Henry D, Teehan BP, Rudnick MR, Benz RL. Health-related quality of life associated with recombinant human erythropoietin therapy for predialysis chronic renal disease patients. Am J Kidney Dis. 1995 Apr;25(4):548-54. doi: 10.1016/0272-6386(95)90122-1.

  PMID: 7702049 BACKGROUND

• Xue JL, St Peter WL, Ebben JP, Everson SE, Collins AJ. Anemia treatment in the pre-ESRD period and associated mortality in elderly patients. Am J Kidney Dis. 2002 Dec;40(6):1153-61. doi: 10.1053/ajkd.2002.36861.

  PMID: 12460033 BACKGROUND

• Stenvinkel P, Barany P. Anaemia, rHuEPO resistance, and cardiovascular disease in end-stage renal failure; links to inflammation and oxidative stress. Nephrol Dial Transplant. 2002;17 Suppl 5:32-7. doi: 10.1093/ndt/17.suppl_5.32.

  PMID: 12091605 BACKGROUND

• Kimmel PL, Phillips TM, Simmens SJ, Peterson RA, Weihs KL, Alleyne S, Cruz I, Yanovski JA, Veis JH. Immunologic function and survival in hemodialysis patients. Kidney Int. 1998 Jul;54(1):236-44. doi: 10.1046/j.1523-1755.1998.00981.x.

  PMID: 9648084 BACKGROUND

• Stenvinkel P. Inflammation in end-stage renal failure: could it be treated? Nephrol Dial Transplant. 2002;17 Suppl 8:33-8; discussion 40. doi: 10.1093/ndt/17.suppl_8.33.

  PMID: 12147775 BACKGROUND

• Shlipak MG, Fried LF, Cushman M, Manolio TA, Peterson D, Stehman-Breen C, Bleyer A, Newman A, Siscovick D, Psaty B. Cardiovascular mortality risk in chronic kidney disease: comparison of traditional and novel risk factors. JAMA. 2005 Apr 13;293(14):1737-45. doi: 10.1001/jama.293.14.1737.

  PMID: 15827312 BACKGROUND

• Meuwese CL, Stenvinkel P, Dekker FW, Carrero JJ. Monitoring of inflammation in patients on dialysis: forewarned is forearmed. Nat Rev Nephrol. 2011 Mar;7(3):166-76. doi: 10.1038/nrneph.2011.2.

  PMID: 21358695 BACKGROUND

• Gow AJ, Luchsinger BP, Pawloski JR, Singel DJ, Stamler JS. The oxyhemoglobin reaction of nitric oxide. Proc Natl Acad Sci U S A. 1999 Aug 3;96(16):9027-32. doi: 10.1073/pnas.96.16.9027.

  PMID: 10430889 BACKGROUND

• Yilmaz MI, Sonmez A, Saglam M, Gulec M, Kilic S, Eyileten T, Caglar K, Oguz Y, Vural A, Yenicesu M, Zoccali C. Hemoglobin is inversely related to flow-mediated dilatation in chronic kidney disease. Kidney Int. 2009 Jun;75(12):1316-1321. doi: 10.1038/ki.2009.63. Epub 2009 Mar 4.

  PMID: 19262460 BACKGROUND

• Boulanger CM, Amabile N, Guerin AP, Pannier B, Leroyer AS, Mallat CN, Tedgui A, London GM. In vivo shear stress determines circulating levels of endothelial microparticles in end-stage renal disease. Hypertension. 2007 Apr;49(4):902-8. doi: 10.1161/01.HYP.0000259667.22309.df. Epub 2007 Feb 19.

  PMID: 17309952 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Romina A. Danguilan, M.D.

  National Kidney and Transplant Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: September 18, 2017
• Study Start: October 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

PH (1)