the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

NCT ID: NCT03427944

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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To investigate the feasibility of calcium dobesilate in the treatment of microvascular injury provides new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

Detailed Description

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The deterioration of renal function is closely related to microvascular damage, calcium dobesilate is known as microcirculation protective agent, the investigators will further study its effect of non dialysis patients with chronic renal failure and explore the feasibility of calcium dobesilate in treatment of renal microvascular injury, the investigators will provide new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

Conditions

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Chronic Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Calcium Dobesilate group

Calcium dobesilate group was treated with calcium dobesilate (500mg, tid , po), its conservative treatment was the same as that of the conventional treatment group

Group Type ACTIVE_COMPARATOR

Calcium Dobesilate group

Intervention Type DRUG

Calcium dobesilate was used to treat patients with chronic renal failure on the basis of conventional treatment.

Conventional Treatment group

conventional treatment group was treated with conventional conservative treatment of renal failure (low protein, low salt, low fat, low phosphorus diet, balance the internal environment; control blood pressure ; remove intestinal toxins etc.)

Group Type PLACEBO_COMPARATOR

Conventional Treatment group

Intervention Type DRUG

Conventional treatment were used to treat patients with chronic renal failure.

Interventions

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Calcium Dobesilate group

Calcium dobesilate was used to treat patients with chronic renal failure on the basis of conventional treatment.

Intervention Type DRUG

Conventional Treatment group

Conventional treatment were used to treat patients with chronic renal failure.

Intervention Type DRUG

Other Intervention Names

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Treatment group Control group

Eligibility Criteria

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Inclusion Criteria

* Enroll the non dialysis patients with chronic renal failure hospitalized in the Department of Nephrology of the Affiliated Hospital of Xuzhou Medical University.
* According to the glomerular filtration rate, the patients who were not required to be dialysate were at CKD3-5 (GFR between 10 and 59ml/min).

Exclusion Criteria

* Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis.
* Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong Sun, MD

Role: STUDY_DIRECTOR

The Affiliated Hospital of Xuzhou Medical University

Locations

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Sun, MD

Role: CONTACT

15862158578

Facility Contacts

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Dong Sun, MD

Role: primary

15862158578

References

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Berthet P, Farine JC, Barras JP. Calcium dobesilate: pharmacological profile related to its use in diabetic retinopathy. Int J Clin Pract. 1999 Dec;53(8):631-6.

Reference Type BACKGROUND
PMID: 10692760 (View on PubMed)

Tejerina T, Ruiz E. Calcium dobesilate: pharmacology and future approaches. Gen Pharmacol. 1998 Sep;31(3):357-60. doi: 10.1016/s0306-3623(98)00040-8.

Reference Type BACKGROUND
PMID: 9703201 (View on PubMed)

Brunet J, Farine JC, Garay RP, Hannaert P. In vitro antioxidant properties of calcium dobesilate. Fundam Clin Pharmacol. 1998;12(2):205-12. doi: 10.1111/j.1472-8206.1998.tb00943.x.

Reference Type BACKGROUND
PMID: 9565776 (View on PubMed)

Szabo ME, Haines D, Garay E, Chiavaroli C, Farine JC, Hannaert P, Berta A, Garay RP. Antioxidant properties of calcium dobesilate in ischemic/reperfused diabetic rat retina. Eur J Pharmacol. 2001 Oct 5;428(2):277-86. doi: 10.1016/s0014-2999(01)01196-7.

Reference Type BACKGROUND
PMID: 11675046 (View on PubMed)

Brunet J, Farine JC, Garay RP, Hannaert P. Angioprotective action of calcium dobesilate against reactive oxygen species-induced capillary permeability in the rat. Eur J Pharmacol. 1998 Oct 9;358(3):213-20. doi: 10.1016/s0014-2999(98)00604-9.

Reference Type BACKGROUND
PMID: 9822887 (View on PubMed)

Padilla E, Ganado P, Sanz M, Zeini M, Ruiz E, Trivino A, Ramirez AI, Salazar JJ, Ramirez JM, Rojas B, Hoz Rd, Tejerina T. Calcium dobesilate attenuates vascular injury and the progression of diabetic retinopathy in streptozotocin-induced diabetic rats. Diabetes Metab Res Rev. 2005 Mar-Apr;21(2):132-42. doi: 10.1002/dmrr.487.

Reference Type BACKGROUND
PMID: 15386814 (View on PubMed)

Ruiz E, Lorente R, Tejerina T. Effects of calcium dobesilate on the synthesis of endothelium-dependent relaxing factors in rabbit isolated aorta. Br J Pharmacol. 1997 Jun;121(4):711-6. doi: 10.1038/sj.bjp.0701184.

Reference Type BACKGROUND
PMID: 9208138 (View on PubMed)

Lozovskaia EL, Kaplunskii GD, Sapezhinskii II. [Superoxide dismutase activity and photosensitizing properties of 2,5-dihydroxybenzolsulfonate]. Biofizika. 1990 Nov-Dec;35(6):912-6. Russian.

Reference Type BACKGROUND
PMID: 1965686 (View on PubMed)

Garay RP, Hannaert P, Chiavaroli C. Calcium dobesilate in the treatment of diabetic retinopathy. Treat Endocrinol. 2005;4(4):221-32. doi: 10.2165/00024677-200504040-00003.

Reference Type BACKGROUND
PMID: 16053339 (View on PubMed)

Demirtas S, Caliskan A, Guclu O, Yazici S, Karahan O, Yavuz C, Mavitas B. Can calcium dobesilate be used safely for peripheral microvasculopathies that require neoangiogenesis? Med Sci Monit Basic Res. 2013 Sep 27;19:253-7. doi: 10.12659/MSMBR.889427.

Reference Type BACKGROUND
PMID: 24072135 (View on PubMed)

Larsen HW, Sander E, Hoppe R. The value of calcium dobesilate in the treatment of diabetic retinopathy. A controlled clinical trial. Diabetologia. 1977 Apr;13(2):105-9. doi: 10.1007/BF00745136.

Reference Type BACKGROUND
PMID: 323093 (View on PubMed)

Allain H, Ramelet AA, Polard E, Bentue-Ferrer D. Safety of calcium dobesilate in chronic venous disease, diabetic retinopathy and haemorrhoids. Drug Saf. 2004;27(9):649-60. doi: 10.2165/00002018-200427090-00003.

Reference Type BACKGROUND
PMID: 15230646 (View on PubMed)

Angulo J, Peiro C, Romacho T, Fernandez A, Cuevas B, Gonzalez-Corrochano R, Gimenez-Gallego G, de Tejada IS, Sanchez-Ferrer CF, Cuevas P. Inhibition of vascular endothelial growth factor (VEGF)-induced endothelial proliferation, arterial relaxation, vascular permeability and angiogenesis by dobesilate. Eur J Pharmacol. 2011 Sep 30;667(1-3):153-9. doi: 10.1016/j.ejphar.2011.06.015. Epub 2011 Jun 22.

Reference Type BACKGROUND
PMID: 21703259 (View on PubMed)

Barr CC. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive insulin therapy, by The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. N. Engl. J. Med 342:381-9, 2000. Surv Ophthalmol. 2001 Mar-Apr;45(5):459-60. doi: 10.1016/s0039-6257(01)00187-4. No abstract available.

Reference Type BACKGROUND
PMID: 11274700 (View on PubMed)

Ribeiro ML, Seres AI, Carneiro AM, Stur M, Zourdani A, Caillon P, Cunha-Vaz JG; DX-Retinopathy Study Group. Effect of calcium dobesilate on progression of early diabetic retinopathy: a randomised double-blind study. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1591-600. doi: 10.1007/s00417-006-0318-2.

Reference Type BACKGROUND
PMID: 16763797 (View on PubMed)

Leal EC, Martins J, Voabil P, Liberal J, Chiavaroli C, Bauer J, Cunha-Vaz J, Ambrosio AF. Calcium dobesilate inhibits the alterations in tight junction proteins and leukocyte adhesion to retinal endothelial cells induced by diabetes. Diabetes. 2010 Oct;59(10):2637-45. doi: 10.2337/db09-1421. Epub 2010 Jul 13.

Reference Type BACKGROUND
PMID: 20627932 (View on PubMed)

Velpandian T, Nirmal J, Gupta P, Vijayakumar AR, Ghose S. Evaluation of calcium dobesilate for its anti-cataract potential in experimental animal models. Methods Find Exp Clin Pharmacol. 2010 Apr;32(3):171-9. doi: 10.1358/mf.2010.32.3.1423888.

Reference Type BACKGROUND
PMID: 20448859 (View on PubMed)

Other Identifiers

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XYFY2016-KL001-02

Identifier Type: -

Identifier Source: org_study_id

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