Brief Summary
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.
Brief Title
Alkali Therapy in Chronic Kidney Disease
Completion Date
Completion Date Type
Actual
Conditions
Chronic Kidney Disease
Metabolic Acidosis
Eligibility Criteria
Inclusion Criteria:
* Estimate GFR \<= 45 and \>15 ml/min/1.73m2
* Age \>18
Exclusion Criteria:
* Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* bicarbonate level \<20 or \>25 mEq/L
* New York Heart Association Class III or IV heart failure
* Systolic blood pressure \>180 mmHg
* Initiation of ESRD treatment planned within 6 months
* Kidney transplantation
* Treatment with immunosuppressives within the last 3 months
* Estimate GFR \<= 45 and \>15 ml/min/1.73m2
* Age \>18
Exclusion Criteria:
* Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* bicarbonate level \<20 or \>25 mEq/L
* New York Heart Association Class III or IV heart failure
* Systolic blood pressure \>180 mmHg
* Initiation of ESRD treatment planned within 6 months
* Kidney transplantation
* Treatment with immunosuppressives within the last 3 months
Inclusion Criteria
Inclusion Criteria:
* Estimate GFR \<= 45 and \>15 ml/min/1.73m2
* Age \>18
* Estimate GFR \<= 45 and \>15 ml/min/1.73m2
* Age \>18
Gender
All
Gender Based
false
Keywords
Alkali
Sodium bicarbonate
Kidney disease
Acidosis
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
19 Years
NCT Id
NCT01452412
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2009-408
Overall Status
Completed
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease
Primary Outcomes
Outcome Description
Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.
Outcome Measure
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
Outcome Time Frame
2 year
Outcome Description
The investigators will evaluate changes in bone mineral density at the wrist.
Outcome Measure
DEXA of Wrist
Outcome Time Frame
2 year
Secondary Ids
Secondary Id
R01DK087783
Secondary Outcomes
Outcome Description
Hand-grip strength will be measured in all participants
Outcome Time Frame
2 year
Outcome Measure
Hand-grip Strength
Outcome Description
Estimated GFR
Outcome Time Frame
2 year
Outcome Measure
Estimated GFR
Outcome Description
Short Form- 36 (SF-36) will be performed in all participants. We will evaluate effects on the Physical Function Domain. The Physical Function Domain is scored from 0 to 100 with higher scores meaning better physical functioning.
Outcome Time Frame
2 year
Outcome Measure
Quality of Life - Physical Function Domain
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
19
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michal Melamed
Investigator Email
michal.melamed@einsteinmed.org
Investigator Phone
718-430-2304