Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
|ClinicalTrials.gov Identifier: NCT01574157|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Renal Insufficiency Diabetes Mellitus||Drug: Sodium bicarbonate Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Investigations of the Optimum Serum Bicarbonate Level in Renal Disease|
|Actual Study Start Date :||November 5, 2012|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||July 1, 2018|
Active Comparator: Arm 1
Drug: Sodium bicarbonate
Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
Placebo Comparator: Arm 2
Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
- Change in urinary transforming growth factor beta 1 (TGF-b1) [ Time Frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value. ]Urinary TGF-b1 is considered a marker of renal fibrosis
- Change in urinary Bb and membrane attack complex (MAC) [ Time Frame: The mean of the 3-month and 6-month urinary Bb and MAC measurements will be compared to the baseline values. ]These are biomarkers of renal complement system activation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574157
|United States, Utah|
|VA Salt Lake City Health Care System, Salt Lake City, UT|
|Salt Lake City, Utah, United States, 84148|
|Principal Investigator:||Kalani L Raphael, MD||VA Salt Lake City Health Care System, Salt Lake City, UT|