Unique ID issued by UMIN | UMIN000001003 |
---|---|
Receipt number | R000001210 |
Scientific Title | A randomized trial of the beta-adrenergic antagonist carvedilol in chronic kidney disease |
Date of disclosure of the study information | 2008/02/22 |
Last modified on | 2008/01/31 17:41:27 |
A randomized trial of the beta-adrenergic antagonist carvedilol in chronic kidney
disease
CArvedilol REnoprotective CKD trial: CARE-CKD trial
A randomized trial of the beta-adrenergic antagonist carvedilol in chronic kidney
disease
CArvedilol REnoprotective CKD trial: CARE-CKD trial
Japan |
Chronic kidney disease at stage of 3, 4 and 5
Nephrology |
Others
NO
To ask whether patients with CKD stage 3, 4 and 5 may obtain more renoprotection with an add-on of carvedilol on the top of standard CKD treatment.
Efficacy
Exploratory
Explanatory
Phase III
A combined renal outcome of a doubling of serum creatinine concentration and/or end-stage renal disease
1) estimated glomerular filtration rate
2) dairy proteinuria excretion
3) blood pressure, heart rate
4) cardiovascular events
5) cardiac ultrasound
6) blood neurohormones, hANP, and BNP levels
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Medicine |
Eligible patients with CKD stage 3, 4 and 5 were enrolled in a parallel, open-label, placebo controlled, randomized treatment protocol. During a run-in phase of about one month, all patients received 1.25 mg of carvedilol two times a day in order to determine which patients were unable to tolerate low doses of carvedilol.
The patients were requested to visit their doctors every two weeks for their medical checks. Patients who could not tolerate such a dose were excluded from this trial. Remaining patients were then randomly assigned to receive either placebo or carvedilol by 1:1 stratified randomization. They continued their background treatment for renoprotection. During the titration period, the dose of carvedilol was doubled at one-month interval and then increased to a target dose of 10 mg twice a day. When the dose increase was not tolerated for the appearance of adverse reactions such as symptomatic fatigue, HR <50 beats/min or arterial hypotension (BP <90/60 mm Hg), it was temporarily halved, then again increased at same interval. The final dose of carvedilol was individually titrated. At the end of the up-titration phase, the therapy with carvedilol or placebo was maintained to the end of this study of three years. Antihypertensive agents with dihydropyridine calcium channel blockers, ACE inhibitors, angiotensin II receptor antagonists and others was maintained, although the dosage was adjusted according to the clinical conditions of the patient or to the appearance of side effects possibly related to these drugs. First agent to consider was dihydropyridine calcium channel blockers, while the RAAS blockers were last agent to adjust. A total experimental period was 2.5 years.
The same protocol was followed for patients allocated to the placebo group.
18 | years-old | <= |
70 | years-old | >= |
Male and Female
Age 18 - 70 years, chronic kidney disease stage 3, 4 and 5, as defined by the Japanese Society of Nephrology (JSN), standard renoprotective treatment recommended by the JSN committee, their physical status and laboratory results maintained with variation of less than 30% during at least three consecutive measurements, for a minimum of 3 months after the first consultation, without evidence of urinary-tract infection or overt heart failure (New York Heart Association [NYHA] class III-IV) and acute cardiovascular acidents; and no history of allergic reaction to drugs, especially beta-adrenergic antagonists.
Exclusion criteria were: immediate need for renal replacement therapy; treatment-resistant oedema; need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs; proteinuria greater than 10 g per day and hypoalbuminaemia less than 28 g/L (normal range 36–50 g/L); renovascular hypertension; malignant hypertension, myocardial infarction, or cerebrovascular accident in the year preceding the trial; severe peripheral vascular disease; severe congestive heart failure (NYHA III–IV); chronic hepatic disease (rise of serum aminotransferase concentration); connective-tissue disease; obstructive uropathy; cancer; chronic pulmonary disease; drug or alcohol misuse; pregnancy; and breastfeeding.
200
1st name | |
Middle name | |
Last name | Naoyuki Nakao |
Rokko Island Hospital
Division of Nephrology
KoYo-cho naka 2-11, Higashinada, kobe
078-858-1111
1st name | |
Middle name | |
Last name | Naoyuki Nakao |
Rokko Island Hospital
Division of Nephrology
KoYoCho naka 2-11 Higashinada Kobe Hyogo Japan
078-858-1111
Rokko Island Hospital-Clinical Research Committee
None
Self funding
None
None
NO
2008 | Year | 02 | Month | 22 | Day |
Partially published
Renoprotective efficacy of carvedilol, presented at theAnnual scientific meeting of American Society of nephrology in 2007 (SA-FC039).
Completed
1995 | Year | 04 | Month | 19 | Day |
1995 | Year | 05 | Month | 01 | Day |
2007 | Year | 11 | Month | 01 | Day |
2008 | Year | 02 | Month | 01 | Day |
2008 | Year | 02 | Month | 01 | Day |
2008 | Year | 05 | Month | 01 | Day |
2008 | Year | 01 | Month | 31 | Day |
2008 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001210
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |