Trial Outcomes & Findings for Alkali Therapy in Chronic Kidney Disease (NCT NCT01452412)

NCT ID: NCT01452412

Last Updated: 2020-01-07

Results Overview

Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 149 participants
• Primary outcome timeframe: 2 year
• Results posted on: 2020-01-07

Participant Flow

Participant milestones

Measure	Sodium Bicarbonate 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
Overall Study STARTED	74	75
Overall Study COMPLETED	46	58
Overall Study NOT COMPLETED	28	17

Reasons for withdrawal

Measure	Sodium Bicarbonate 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
Overall Study Withdrawal by Subject	15	11
Overall Study Adverse Event	4	3
Overall Study Lost to Follow-up	5	3
Overall Study Death	1	0
Overall Study Initiated dialysis	1	0
Overall Study Other	2	0

Baseline Characteristics

Alkali Therapy in Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Sodium Bicarbonate n=74 Participants 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 Participants placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm	Total n=149 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 14.1 • n=5 Participants	61.6 years STANDARD_DEVIATION 10.9 • n=7 Participants	61 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	42 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants	63 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	39 Participants n=5 Participants	47 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	16 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Serum bicarbonate	24 mEq/L STANDARD_DEVIATION 2.2 • n=5 Participants	24.1 mEq/L STANDARD_DEVIATION 2.6 • n=7 Participants	24 mEq/L STANDARD_DEVIATION 2.2 • n=5 Participants
estimated glomerular filtration rate (eGFR)	36.2 ml/min/1.73m2 STANDARD_DEVIATION 11.1 • n=5 Participants	36.4 ml/min/1.73m2 STANDARD_DEVIATION 11.4 • n=7 Participants	36.3 ml/min/1.73m2 STANDARD_DEVIATION 11.2 • n=5 Participants

PRIMARY outcome

Timeframe: 2 year

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 measures

Measure	Sodium Bicarbonate n=74 Participants 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 Participants placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times	23.8 seconds Standard Deviation 5.8	22.9 seconds Standard Deviation 6.5

PRIMARY outcome

Timeframe: 2 year

The investigators will evaluate changes in bone mineral density at the wrist.

Outcome measures

Measure	Sodium Bicarbonate n=74 Participants 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 Participants placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
DEXA of Wrist	0.75 g/cm2 Standard Deviation 0.23	0.73 g/cm2 Standard Deviation 0.17

SECONDARY outcome

Timeframe: 2 year

Hand-grip strength will be measured in all participants

Outcome measures

Measure	Sodium Bicarbonate n=74 Participants 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 Participants placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
Hand-grip Strength	27.3 kg Standard Deviation 9.8	24.9 kg Standard Deviation 10.2

SECONDARY outcome

Timeframe: 2 year

Estimated GFR

Outcome measures

Measure	Sodium Bicarbonate n=74 Participants 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 Participants placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
Estimated GFR	38.5 ml/min/1.73m2 Standard Deviation 17.7	36.3 ml/min/1.73m2 Standard Deviation 14.5

SECONDARY outcome

Timeframe: 2 year

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 measures

Measure	Sodium Bicarbonate n=74 Participants 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 Participants placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
Quality of Life - Physical Function Domain	40 score on a scale Standard Deviation 12	43 score on a scale Standard Deviation 11

Adverse Events

Sodium Bicarbonate

Serious events: 20 serious events

Other events: 29 other events

Deaths: 1 deaths

Placebo

Serious events: 15 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sodium Bicarbonate n=74 participants at risk 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 participants at risk placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
General disorders All-cause hospitalization	27.0% 20/74 • Number of events 20	20.0% 15/75 • Number of events 15

Other adverse events

Measure	Sodium Bicarbonate n=74 participants at risk 0.4 mEq/kg/day ideal body weight to be taken once a day Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day	Placebo n=75 participants at risk placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm
Renal and urinary disorders Serum bicarbonate >=30	12.2% 9/74 • Number of events 9	6.7% 5/75 • Number of events 5
Renal and urinary disorders Serum bicarbonate <=18	2.7% 2/74 • Number of events 2	5.3% 4/75 • Number of events 4
Renal and urinary disorders Serum potassium <=3.5	5.4% 4/74 • Number of events 4	2.7% 2/75 • Number of events 2
Renal and urinary disorders Serum potassium >= 5.0 mEq/L	18.9% 14/74 • Number of events 14	40.0% 30/75 • Number of events 30

Additional Information

Michal Melamed, MD

Albert Einstein College of Medicine

Phone: 718-430-2496

Email: michal.melamed@einstein.yu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place