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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Azienda Sanitaria ASL Avellino 2
Information provided by (Responsible Party):
Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2 Identifier:
First received: June 28, 2012
Last updated: September 17, 2014
Last verified: September 2014

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 Intervention Phase
Metabolic Acidosis
Dietary Supplement: Bicarbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Azienda Sanitaria ASL Avellino 2:

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

Secondary Outcome Measures:
  • all-cause death [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
    all-cause death of patients

  • start of renal replacement therapy [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
    start of dialysis (peritoneal dialysis or hemodialysis)

Estimated Enrollment: 728
Study Start Date: July 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: no intervention
Experimental: Bicarbonate Dietary Supplement: Bicarbonate
bicarbonate administration
Other Name: Alkali

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01640119

Contact: Biagio Di Iorio, chair 00390825530366

UOC di Nefrologia Not yet recruiting
Solofra, Avellino, Italy, I-83029
Contact: Biagio Di Iorio, Chair    00390825 530 366   
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   
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
Principal Investigator: Biagio Di Iorio, MD, PhD Azienda Sanitaria ASL Avellino 2
  More Information

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. 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

Responsible Party: Dr Biagio Di Iorio, Principal Investigator, Azienda Sanitaria ASL Avellino 2 Identifier: NCT01640119     History of Changes
Other Study ID Numbers: aslav2
Study First Received: June 28, 2012
Last Updated: September 17, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Sanitaria ASL Avellino 2:
metabolic acidosis
renal death

Additional relevant MeSH terms:
Kidney Failure, Chronic
Acid-Base Imbalance
Kidney Diseases
Metabolic Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases processed this record on October 09, 2015