the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

Chronic Renal Failure Clinical Trial

Official title:

the Effect of Calcium Dobesilate on Non Dialysis Patients With Chronic Renal Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03427944
• Other study ID #: XYFY2016-KL001-02
• Status: Recruiting
• Phase: Phase 4
• First received: January 17, 2018
• Last updated: February 12, 2018
• Start date: January 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: Dong Sun, MD
• Phone: 15862158578
• Email: sundong126[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Calcium Dobesilate group
Calcium dobesilate was used to treat patients with chronic renal failure on the basis of conventional treatment.
• Conventional Treatment group
Conventional treatment were used to treat patients with chronic renal failure.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (17)

Allain H, Ramelet AA, Polard E, Bentué-Ferrer D. Safety of calcium dobesilate in chronic venous disease, diabetic retinopathy and haemorrhoids. Drug Saf. 2004;27(9):649-60. Review. — View Citation

Angulo J, Peiró C, Romacho T, Fernández A, Cuevas B, González-Corrochano R, Giménez-Gallego G, de Tejada IS, Sánchez-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Brunet J, Farine JC, Garay RP, Hannaert P. In vitro antioxidant properties of calcium dobesilate. Fundam Clin Pharmacol. 1998;12(2):205-12. — View Citation

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. — View Citation

Garay RP, Hannaert P, Chiavaroli C. Calcium dobesilate in the treatment of diabetic retinopathy. Treat Endocrinol. 2005;4(4):221-32. — View Citation

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. — View Citation

Leal EC, Martins J, Voabil P, Liberal J, Chiavaroli C, Bauer J, Cunha-Vaz J, Ambrósio 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. — View Citation

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. — View Citation

Padilla E, Ganado P, Sanz M, Zeini M, Ruiz E, Triviño A, Ramírez AI, Salazar JJ, Ramírez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tejerina T, Ruiz E. Calcium dobesilate: pharmacology and future approaches. Gen Pharmacol. 1998 Sep;31(3):357-60. Review. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glomerular filtration rate	emission computed tomography	up to 6 months
Secondary	serum creatinine	intravenous blood sampling	up to 6 months
Secondary	Cystatin C	intravenous blood sampling	up to 6 months