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

NCT01640119 | Unknown Phase 3 DMC

• 1 other identifier: aslav2
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 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.

Conditions

Metabolic Acidosis

Keywords

metabolic acidosis; renal death

Outcome Measures

Primary Outcomes (1)

• doubling of creatinine

  the primary outcome will be reached when the seric creatinine level (mg/dl) will double compared to the basal value.

  36 months

Secondary Outcomes (2)

• all-cause death

  36 month

• start of renal replacement therapy

  36 month

Study Arms (2)

no intervention

PLACEBO COMPARATOR

Bicarbonate

EXPERIMENTAL

Dietary Supplement: Bicarbonate

Interventions

Bicarbonate DIETARY_SUPPLEMENT

bicarbonate administration

Also known as: Alkali

Bicarbonate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End stage renal disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria ASL Avellino 2: lead

Study Sites (2)

UOC di Nefrologia

Solofra, Avellino, I-83029, Italy

NOT YET RECRUITING

UOC do Nefrologia

Solofra, Avellino, I-83029, Italy

RECRUITING

Related Publications (3)

• 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

  BACKGROUND

• Di Iorio BR, Bellasi A, Raphael KL, Santoro D, Aucella F, Garofano L, Ceccarelli M, Di Lullo L, Capolongo G, Di Iorio M, Guastaferro P, Capasso G; UBI Study Group. Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study. J Nephrol. 2019 Dec;32(6):989-1001. doi: 10.1007/s40620-019-00656-5. Epub 2019 Oct 9.

  PMID: 31598912 DERIVED

• Bellasi A, Di Micco L, Santoro D, Marzocco S, De Simone E, Cozzolino M, Di Lullo L, Guastaferro P, Di Iorio B; UBI study investigators. Correction of metabolic acidosis improves insulin resistance in chronic kidney disease. BMC Nephrol. 2016 Oct 22;17(1):158. doi: 10.1186/s12882-016-0372-x.

  PMID: 27770799 DERIVED

MeSH Terms

Conditions

Acidosis

Interventions

Bicarbonates; Alkalies

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Study Officials

• Biagio Di Iorio, MD, PhD

  Azienda Sanitaria ASL Avellino 2

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biagio Di Iorio, chair

CONTACT

00390825530366; br.diiorio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2017
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

IT (2)