the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

NCT03427944 | Unknown Phase 4 DMC

• 1 other identifier: XYFY2016-KL001-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Renal Failure

Keywords

Calcium Dobesilate; Non Dialysis Patients With CKD(3-5); Glomerular filtration rate; serum creatinine

Outcome Measures

Primary Outcomes (1)

• glomerular filtration rate

  emission computed tomography

  up to 6 months

Secondary Outcomes (2)

• serum creatinine

  up to 6 months

• Cystatin C

  up to 6 months

Study Arms (2)

Calcium Dobesilate group

ACTIVE COMPARATOR

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

Drug: Calcium Dobesilate group

Conventional Treatment group

PLACEBO COMPARATOR

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.)

Drug: Conventional Treatment group

Interventions

Calcium Dobesilate group DRUG

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

Also known as: Treatment group

Calcium Dobesilate group

Conventional Treatment group DRUG

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

Also known as: Control group

Conventional Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (17)

• 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.

  PMID: 10692760 BACKGROUND

• 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.

  PMID: 9703201 BACKGROUND

• 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.

  PMID: 9565776 BACKGROUND

• 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.

  PMID: 11675046 BACKGROUND

• 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.

  PMID: 9822887 BACKGROUND

• 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.

  PMID: 15386814 BACKGROUND

• 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.

  PMID: 9208138 BACKGROUND

• 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.

  PMID: 1965686 BACKGROUND

• 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.

  PMID: 16053339 BACKGROUND

• 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.

  PMID: 24072135 BACKGROUND

• 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.

  PMID: 323093 BACKGROUND

• 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.

  PMID: 15230646 BACKGROUND

• 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.

  PMID: 21703259 BACKGROUND

• 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.

  PMID: 11274700 BACKGROUND

• 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.

  PMID: 16763797 BACKGROUND

• 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.

  PMID: 20627932 BACKGROUND

• 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.

  PMID: 20448859 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dong Sun, MD

  The Affiliated Hospital of Xuzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Dong Sun, MD

CONTACT

15862158578; sundong126@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 9, 2018
• Study Start: January 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)