NCT01225796

Brief Summary

The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1 (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate levels (20 - 28 mmol/L).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

October 15, 2010

Last Update Submit

April 5, 2016

Conditions

Kidney Transplantation

Keywords

BicarbonateChronic allograft nephropathyUrinary TGF-betaUrinary acid excretion

Outcome Measures

Primary Outcomes (1)

  • Urinary transforming growth factor-beta1

    This is considered a surrogate marker of chronic allograft nephropathy (tubulointerstitial fibrosis).

    6 months

Secondary Outcomes (1)

  • urinary ammonia excretion

    6 months

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

This group will receive oral sodium bicarbonate 650mg three times daily for 6 months.

Drug: Sodium bicarbonate

Control

NO INTERVENTION

This group will not receive any sodium bicarbonate.

Interventions

Sodium bicarbonateDRUG

Sodium bicarbonate 650mg by mouth three times daily for 6 months.

Sodium bicarbonate

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplant recipients
  • Age 21-75 years
  • Six months since the time of the most recent transplant
  • Serum bicarbonate 20-28mM on the two most recent serum measures with the last six months
  • Stable creatinine

You may not qualify if:

  • Systolic blood pressure \> 140mmHg
  • Diastolic blood pressure \> 90mmHg
  • Known ejection fraction \<50%
  • Clinical diagnosis of heart failure
  • Use of \>3 antihypertensive agents
  • \> 1+ edema
  • Use of alkali in the preceding 3 months
  • History of noncompliance with clinic visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (4)

  • de Brito-Ashurst I, Varagunam M, Raftery MJ, Yaqoob MM. Bicarbonate supplementation slows progression of CKD and improves nutritional status. J Am Soc Nephrol. 2009 Sep;20(9):2075-84. doi: 10.1681/ASN.2008111205. Epub 2009 Jul 16.

    PMID: 19608703BACKGROUND

  • Amara AB, Sharma A, Alexander JL, Alfirevic A, Mohiuddin A, Pirmohamed M, Close GL, Grime S, Maltby P, Shawki H, Heyworth S, Shenkin A, Smith L, Sharma AK, Hammad A, Rustom R. Randomized controlled trial: lisinopril reduces proteinuria, ammonia, and renal polypeptide tubular catabolism in patients with chronic allograft nephropathy. Transplantation. 2010 Jan 15;89(1):104-14. doi: 10.1097/TP.0b013e3181bf13d9.

    PMID: 20061926BACKGROUND

  • Mahajan A, Simoni J, Sheather SJ, Broglio KR, Rajab MH, Wesson DE. Daily oral sodium bicarbonate preserves glomerular filtration rate by slowing its decline in early hypertensive nephropathy. Kidney Int. 2010 Aug;78(3):303-9. doi: 10.1038/ki.2010.129. Epub 2010 May 5.

    PMID: 20445497BACKGROUND

  • Raphael KL, Wei G, Baird BC, Greene T, Beddhu S. Higher serum bicarbonate levels within the normal range are associated with better survival and renal outcomes in African Americans. Kidney Int. 2011 Feb;79(3):356-62. doi: 10.1038/ki.2010.388. Epub 2010 Oct 20.

    PMID: 20962743BACKGROUND

MeSH Terms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Kalani L Raphael, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 21, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)