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Correction of Metabolic Acidosis in End Stage Renal Disease (ESRD) (UBI)

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ClinicalTrials.gov Identifier: NCT01640119
Recruitment Status : Unknown
Verified September 2014 by Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2.
Recruitment status was:  Recruiting
First Posted : July 13, 2012
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2

Brief Summary:

The investigators want to evaluate whether an original action based on the administration of alkali (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce mortality due to cardiovascular events.

Methods: This is a proposal of Multicentric, prospective, cohort, randomized, open-label and controlled study.

The investigators will Randomize 728 patients with Chronic Kidney Disease(CKD) stage 3b (CKD-3b) and CKD stage 4: 364 of these patients will be included in the study group called Bicarbonate Group (Bic), in which levels of bicarbonate should be kept > 24 mEq/l; the other 364 patients will included in the Usual Treatment Group (no-Bic).

Results: The aim of the Research Protocol is to demonstrate if that the optimal correction of uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing agent, e.g. sodium citrate) reduces renal and cardiovascular mortality.

Conclusions. In conclusion the Work Group of the Conservative Therapy for Chronic Renal Insufficiency proposes this cohort, randomized, controlled, prospective, multicentric study to evaluate the effects of correction of acidosis on the progression of the kidney disease considered as renal death in End-Stage Renal Disease (ESRD) patients.

Condition or disease Intervention/treatment Phase
Metabolic Acidosis Dietary Supplement: Bicarbonate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 728 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Controlled, Randomized, Multicentric Study: Correction of Metabolic Acidosis With Use of Bicarbonate in Chronic Renal Insufficiency (CKD3b-4)
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: no intervention
Experimental: Bicarbonate Dietary Supplement: Bicarbonate
bicarbonate administration
Other Name: Alkali

Primary Outcome Measures :
  1. doubling of creatinine [ Time Frame: 36 months ]
    the primary outcome will be reached when the seric creatinine level (mg/dl) will double compared to the basal value.

Secondary Outcome Measures :
  1. all-cause death [ Time Frame: 36 month ]
    all-cause death of patients

  2. start of renal replacement therapy [ Time Frame: 36 month ]
    start of dialysis (peritoneal dialysis or hemodialysis)

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • End stage renal disease

Exclusion Criteria:

  • Neoplastic diseases

    • Autoimmune diseases
    • Decompensation class III-IV
    • Uncontrollable hypertension
    • Amputation of the limbs
    • Previous ictus cerebri
    • Neobladder, ureterosigmoidostomy
    • Sever acidosis with bicarbonate < 18 mEq/l
    • Use of calcium carbonate (relative exclusion factor: patients who used to take this drug and suspended it before the beginning of the 3-month run-in period can be included in the study).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640119

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Contact: Biagio Di Iorio, chair 00390825530366 br.diiorio@gmail.com

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UOC di Nefrologia Not yet recruiting
Solofra, Avellino, Italy, I-83029
Contact: Biagio Di Iorio, Chair    00390825 530 366    br.diiorio@gmail.com   
Principal Investigator: Biagio Di Iorio, Direttore         
Sub-Investigator: Giovambattista Capasso         
Sub-Investigator: Filippo Aucella         
Sub-Investigator: Adamasco Cupisti         
Sub-Investigator: Domenico Santoro         
UOC do Nefrologia Recruiting
Solofra, Avellino, Italy, I-83029
Contact: Biagio Di Iorio, direttore    00390825530366    br.diiorio@gmail.com   
Principal Investigator: Biagio Di Iorio         
Sub-Investigator: Giovambattista Capasso         
Sub-Investigator: Filippo Aucella         
Sub-Investigator: Domenico Santoro         
Sub-Investigator: Adamasco Cupisti         
Sponsors and Collaborators
Azienda Sanitaria ASL Avellino 2
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Principal Investigator: Biagio Di Iorio, MD, PhD Azienda Sanitaria ASL Avellino 2
1.Eustace JA, et al. Prevalence of acidosis and inflammation and their association with low serum albumin in chronic kidney disease. Kidney Int. 2004 ;65:1031-40. 2.Ballmer PE, et al: Chronic metabolic acidosis decreases albumin synthesis and induces negative nitrogen balance in humans. J Clin Invest 1995;95:39-40 3.Chiu YW, et al: Correction of metabolic acidosis to ameliorate wasting in chronic kidney disease: goals and startegies. Sem Nephrol 2009;29:67-74 4.Bommer J, et al: association of predialysis serum bicarbonate levels with risk of mortality and hospitalization in the DOPPS. Am J Kidney Disease 2004;44:661-671 5.Wu DY, et al: Association between serum bicarbonate and death in hemodialysis patients: is it better to be acidosis or alkalotic? Clin J Am Soc Nephrol 2006;1:70-78 6.Kraut JA, Madias NE. Metabolic acidosis: pathophysiology, diagnosis and management. Nat Rev Nephrol. 2010;6:274-85. 7.Roderick P, et al. Correction of chronic metabolic acidosis for chronic kidney disease patients. Cochrane Database Syst Rev. 2007; Jan 24(1):CD001890. 8.de Brito-Ashurst I, et al: Bicarbonate supplementation slows progression of CKD and improves nutritional status. J Am Soc Nephrol 2009;20:2075-2084 9.Menon V, et al: Serum bicarbonate and long-term outcomes in CKD. Am J Kidney Disease 2010; 56:907-14 10.Wesson DE, Simoni J: Acid retention during kidney failure induces endothelin and aldosterone production which lead to progressive GFR decline, a situation ameliorated by alkali diet. Kidney Int 2010;78 1128-1135

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Biagio Di Iorio, Principal Investigator, Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier: NCT01640119    
Other Study ID Numbers: aslav2
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2:
metabolic acidosis
renal death
Additional relevant MeSH terms:
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Acid-Base Imbalance
Metabolic Diseases