Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Chronic Kidney Disease Clinical Trial

Official title:

Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01820832
• Other study ID #: Calcitriol-MP-1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 19, 2013
• Last updated: March 28, 2013
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2013
• Source: Huashan Hospital
• Contact: Jing Chen, M.D. PhD
• Phone: 86-21-52889387
• Email: chenjing1998[@]fudan.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.

Description:

Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• aged 18-75 years

• clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis

• proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month

• estimated glomerular filtration rate (eGFR)>60ml/min/1/73m2

• corticosteroid and immunosuppressive agents withdrawal for at least 6 months

• normal blood pressure

• serum intact parathyroid hormone (iPTH) level >20pg/mL

• corrected serum calcium level < or = 2.55 mmol/L

• serum phosphorus level < or = 1.68 mmol/L

• 24 hours urinary calcium excretion level < or = 7.5 mmol

• not receive treatment of vitamin D or its analogue within 6 months

• willigness to give written consent and comply with the study protocol

Exclusion Criteria:

• history of sensitivity or allergy to calcitriol or other vitamin D analogs

• pregnancy, lactating women

• history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension

• history of malignancy

• history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases

• patients receiving drugs contains of calcium

• patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption

• participation in any other trials within 1 month

• history of non-compliance

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Drug:
• Calcitriol
Calcitriol 0.5 ug/BIW for 24 weeks.

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mean change of renal function (serum creatine, cystatin C, eGFR)		24 weeks	Yes
Other	blood pressure		24 weeks	Yes
Primary	the percentage change of proteinuia		24 weeks	No
Secondary	the proportion of patients achieving at least a 15% decrease in proteinuria		24 weeks	No