Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Huashan Hospital
Sponsor:
Information provided by (Responsible Party):
Jing Chen, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01820832
First received: March 19, 2013
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
Proteinuria
Drug: Calcitriol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • the percentage change of proteinuia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the proportion of patients achieving at least a 15% decrease in proteinuria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • mean change of renal function (serum creatine, cystatin C, eGFR) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcitriol
General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks.
Drug: Calcitriol
Calcitriol 0.5 ug/BIW for 24 weeks.
Other Name: 1, 25 - dihydroxy Cholecalciferol
No Intervention: Control
General treatments.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820832

Contacts
Contact: Jing Chen, M.D. PhD 86-21-52889387 chenjing1998@fudan.edu.cn
Contact: Li You, M.D. PhD 86-21-52888133 youlizzy@gmail.com

Locations
China, Shanghai
Huashan Hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Li You, M.D. PhD    86-21-52888133    youlizzy@gmail.com   
Sponsors and Collaborators
Huashan Hospital
Investigators
Principal Investigator: Jing Chen, M.D. PhD Division of Nephrology, Huashan Hospital, Fudan University
  More Information

No publications provided

Responsible Party: Jing Chen, Professor, PhD., MD, Renal Division, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01820832     History of Changes
Other Study ID Numbers: Calcitriol-MP-1
Study First Received: March 19, 2013
Last Updated: March 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Huashan Hospital:
mild proteinuria
calcitriol
renal function
blood pressure

Additional relevant MeSH terms:
Proteinuria
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 16, 2014