Trial Outcomes & Findings for A Controlled Study of Uric Acid on the Progression of IgA Nephropathy (NCT NCT00793585)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2016-05-25

Participant Flow

Forty hyperuricemic patients with IgA nephropathy were enrolled in the 1st affiliated hospital of sun yat-sen university between July 2007 and June 2008.

323 primary IgAN patients were screened for enrollment according to inclusion criteria.

Participant milestones

Participant milestones
Measure	Control Group Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.	Allopurinol Group Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr\<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr\>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
Overall Study STARTED	19	21
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.	Allopurinol Group Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr\<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr\>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	1	2

Baseline Characteristics

A Controlled Study of Uric Acid on the Progression of IgA Nephropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=19 Participants Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.	Allopurinol Group n=21 Participants Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr\<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr\>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=99 Participants	21 Participants n=107 Participants	40 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	40.1 years STANDARD_DEVIATION 10.3 • n=99 Participants	39.7 years STANDARD_DEVIATION 10.0 • n=107 Participants	39.9 years STANDARD_DEVIATION 10.1 • n=206 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	8 Participants n=107 Participants	18 Participants n=206 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	13 Participants n=107 Participants	22 Participants n=206 Participants
Region of Enrollment China	19 participants n=99 Participants	21 participants n=107 Participants	40 participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Outcome measures

Outcome measures
Measure	Control Group n=19 Participants Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.	Allopurinol Group n=21 Participants Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr\<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr\>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
Change in Renal Function as Measured With eGFR	68.9 eGFR(min/ml) Standard Deviation 36.6	73.2 eGFR(min/ml) Standard Deviation 34.8

SECONDARY outcome

Timeframe: baseline and 6 months

Population: We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.

Outcome measures

Outcome measures
Measure	Control Group n=19 Participants Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.	Allopurinol Group n=21 Participants Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr\<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr\>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).	1170.4 Upro/cr (mg/g) Standard Deviation 951.9	1219.3 Upro/cr (mg/g) Standard Deviation 1063.6

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Allopurinol Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Xueqing Yu , M.D. & Ph.D.

1st Affiliated Hospital, Sun Yat-Sen University

Phone: 8620-87766335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place