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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr Biagio Di Iorio, Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier:
NCT01640119
First received: June 28, 2012
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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: 600
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no intervention
Experimental: Bicarbonate Dietary Supplement: Bicarbonate
bicarbonate administration
Other Name: Alkali

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01640119

Locations
Italy
UOC di Nefrologia
Solofra, Avellino, Italy, I-83029
UOC do Nefrologia
Solofra, Avellino, Italy, I-83029
Sponsors and Collaborators
Azienda Sanitaria ASL Avellino 2
Investigators
Principal Investigator: Biagio Di Iorio, MD, PhD Azienda Sanitaria ASL Avellino 2
  More Information

No publications provided

Responsible Party: Dr Biagio Di Iorio, Principal Investigator, Azienda Sanitaria ASL Avellino 2
ClinicalTrials.gov Identifier: NCT01640119     History of Changes
Other Study ID Numbers: aslav2
Study First Received: June 28, 2012
Last Updated: July 12, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Acidosis
Kidney Failure, Chronic
Acid-Base Imbalance
Metabolic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014