Back to results

the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

Primary Purpose

Chronic Renal Failure

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Calcium Dobesilate group

Conventional Treatment group

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring Calcium Dobesilate, Non Dialysis Patients With CKD(3-5), Glomerular filtration rate, serum creatinine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Calcium Dobesilate group

Conventional Treatment group

Arm Description

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

Outcomes

Primary Outcome Measures

glomerular filtration rate

emission computed tomography

Secondary Outcome Measures

serum creatinine

intravenous blood sampling

Cystatin C

intravenous blood sampling

Full Information

NCT ID

NCT03427944

First Posted

January 17, 2018

Last Updated

February 12, 2018

Sponsor

The Affiliated Hospital of Xuzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03427944

Brief Title

the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Affiliated Hospital of Xuzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Calcium Dobesilate group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Conventional Treatment group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Calcium Dobesilate group

Other Intervention Name(s)

Treatment group

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Conventional Treatment group

Other Intervention Name(s)

Control group

Intervention Description

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

Primary Outcome Measure Information:

Title

glomerular filtration rate

Description

emission computed tomography

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

serum creatinine

Description

intravenous blood sampling

Time Frame

up to 6 months

Title

Cystatin C

Description

intravenous blood sampling

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Sun, MD

Phone

15862158578

sundong126@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong Sun, MD

Organizational Affiliation

The Affiliated Hospital of Xuzhou Medical University

Official's Role

Study Director

Facility Information:

Facility Name

The Affiliated Hospital of Xuzhou Medical University

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong Sun, MD

Phone

15862158578

sundong126@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10692760

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.

Results Reference

background

PubMed Identifier

9703201

Citation

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.

Results Reference

background

PubMed Identifier

9565776

Citation

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.

Results Reference

background

PubMed Identifier

11675046

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. doi: 10.1016/s0014-2999(01)01196-7.

Results Reference

background

PubMed Identifier

9822887

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. doi: 10.1016/s0014-2999(98)00604-9.

Results Reference

background

PubMed Identifier

15386814

Citation

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.

Results Reference

background

PubMed Identifier

9208138

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. doi: 10.1038/sj.bjp.0701184.

Results Reference

background

PubMed Identifier

1965686

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.

Results Reference

background

PubMed Identifier

16053339

Citation

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.

Results Reference

background

PubMed Identifier

24072135

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.

Results Reference

background

PubMed Identifier

323093

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. doi: 10.1007/BF00745136.

Results Reference

background

PubMed Identifier

15230646

Citation

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.

Results Reference

background

PubMed Identifier

21703259

Citation

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.

Results Reference

background

PubMed Identifier

11274700

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. doi: 10.1016/s0039-6257(01)00187-4. No abstract available.

Results Reference

background

PubMed Identifier

16763797

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. doi: 10.1007/s00417-006-0318-2.

Results Reference

background

PubMed Identifier

20627932

Citation

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.

Results Reference

background

PubMed Identifier

20448859

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.

Results Reference

background

Learn more about this trial

the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

We'll reach out to this number within 24 hrs