Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02338323
Other study ID # FB2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date December 2018

Study information

Verified date July 2019
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether febuxostat and benzbromarone could protect renal function, and which one could be better.


Description:

Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-50 ml/min were treated by febuxostat or benzbromarone. Follow up the changes of serum uric acid, serum creatinine and GFR levels. Compare the effects on renal function of these two drugs.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

Chronic kidney disease patients with glomerular filtration rate (GFR,20-50ml/min) who match one of the following criteria:

1. Gout

2. Hyperuricemia patients without gout but have cardiovascular risk and serum uric acid > 480umol/L

3. Hyperuricemia patients without gout but with serum uric acid > 540umol/L

Exclusion Criteria:

1. GFR<20ml/min or GFR >50ml/min

2. Liver dysfunction (Aspartate transaminase or/and alanine aminotransferase exceed 2 times of normal range)

3. Urinary tract obstruction

4. unstable angina, heart failure (stage III-IV, NYHA), new stroke, need diuretics for long-term treatment

5. Severe lung diseases or cancers

6. Pregnant woman or woman who prepare to be pregnant,nursing mothers

7. unable to sign informed consent form,or disagree with following-up

Study Design


Intervention

Drug:
Febuxostat
It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
Benzbromarone
It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase

Locations

Country Name City State
China Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal function Blood test for serum uric acid and creatinine, according to equation to estimate glomerular filtration rate up to 12th months
Secondary urine protein urine test for microprotein markers and 24-hour urine protein quantitation 3rd months, 6th months, 9th months, 12th months
Secondary adverse drug reaction record all the adverse drug reactions 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4