Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients (CANDLE-KIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01817699
Recruitment Status : Terminated (The independent Data Monitoring Committee recommended an early termination.)
First Posted : March 25, 2013
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Chugai Pharmaceutical
Japanese Society for the Promotion of Science
The Japan Kidney Foundation
Roche Diagnostics
Information provided by (Responsible Party):
CANDLE-KIT Trial Study Group

Brief Summary:
The purpose of this study is to evaluate the effect of anemia correction and vitamin D supplementation in kidney transplant recipients.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Anemia Vitamin D Deficiency Renal Insufficiency, Chronic Other: High Hb target Dietary Supplement: cholecalciferol Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients
Actual Study Start Date : April 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Low Hb target without cholecalciferol
Target Hemoglobin level: ≥9.5 and <10.5 g/dL
Active Comparator: Low Hb target with cholecalciferol
Target Hemoglobin level: ≥9.5 and <10.5 g/dL Cholecalciferol: 1,000 IU/day
Dietary Supplement: cholecalciferol
1,000 IU (1 tablet)/day, orally. Tablets are repacked into blister package.
Other Name: Super vitamin D (Nature Made®)

Active Comparator: High Hb target without cholecalciferol
Target Hemoglobin level: ≥12.5 and <13.5 g/dL
Other: High Hb target

25 to 250 μg of methoxy polyethylene glycol epoetin beta (Mircera®, Chugai pharmaceutical Co. Ltd.) will be administered subcutaneously at 2- to 6-week interval.

Dose and interval will be adjusted according to hemoglobin level and its target.


Experimental: High Hb target with cholecalciferol
Target Hemoglobin level: ≥12.5 and <13.5 g/dL Cholecalciferol: 1,000 IU/day
Other: High Hb target

25 to 250 μg of methoxy polyethylene glycol epoetin beta (Mircera®, Chugai pharmaceutical Co. Ltd.) will be administered subcutaneously at 2- to 6-week interval.

Dose and interval will be adjusted according to hemoglobin level and its target.


Dietary Supplement: cholecalciferol
1,000 IU (1 tablet)/day, orally. Tablets are repacked into blister package.
Other Name: Super vitamin D (Nature Made®)




Primary Outcome Measures :
  1. Change in allograft kidney function [ Time Frame: 2 years ]
    As allograft kidney function, GFR is estimated by the modified MDRD equation for Japanese patients with chronic kidney disease.


Secondary Outcome Measures :
  1. Urine markers of kidney injury [ Time Frame: 6 months ]
    1. protein-creatinine ratio
    2. liver type fatty acid binding protein (L-FABP)
    3. neutrophil gelatinase-associated lipocalin (NGAL)
    4. transforming growth factor (TGF)-β.

  2. The dose of methoxy polyethylene glycol epoetin beta required to maintain the target hemoglobin level [ Time Frame: 1 year ]
    For vitamin D supplementation study only.

  3. Blood pressure [ Time Frame: 2 years ]
  4. Cardiac biomarkers [ Time Frame: 2 years ]
    1. brain natriuretic peptide (BNP)
    2. cardiac troponin-T (cTnT).

  5. Left ventricular mass index [ Time Frame: 2 years ]
  6. Biopsy-proven acute cellular rejection [ Time Frame: 2 years ]
  7. Bone-turnover markers [ Time Frame: 6 months ]
    1. intact parathyroid hormone (1-84 PTH)
    2. bone-type alkaline phosphatase
    3. tartrate-resistant acid phosphatase 5b (TRACP-5b)

    For vitamin D supplementation study only.


  8. Bone mineral density of lumber spine and femoral neck. [ Time Frame: 2 years ]
    For vitamin D supplementation study only.

  9. Hypercalcemia [ Time Frame: 2 years ]

    Corrected calcium ≥11 mg/dL

    For vitamin D supplementation study only.


  10. Time to the renal composite endpoint [ Time Frame: 2 years ]
    renal composite endpoint consists of 50% increase in serum creatinine, subsequent transplantation, and reinitiation of dialysis.

  11. Time to admission-required cardiovascular events [ Time Frame: 2 years ]
    Cardiovascular events includes myocardial infarction, angina, congestive heart failure, stroke, and peripheral artery disease.

  12. Time to all-cause death [ Time Frame: 2 years ]
  13. Time to Cancer development or recurrence [ Time Frame: 2 years ]

Other Outcome Measures:
  1. C-reactive protein [ Time Frame: 1 year ]
    For vitamin D supplementation study only.

  2. Time to the adverse composite endpoint [ Time Frame: 2 years ]
    The adverse composite endpoint consists of death, admission-required cardiovascular diseases, and the renal composite endpoint.

  3. Time to hospitalization for opportunistic infections [ Time Frame: 2 years ]

    Opportunistic infections includes polyomavirus-associated nephropathy, tuberculosis, Pneumocystis carinii pneumonia, cytomegalovirus infection, herpes zoster, bacterial pneumonia.

    For vitamin D supplementation study only.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥15 and <60 ml/min per 1.73 m2 of estimated glomerular filtration rate
  • Transplanted allograft kidney at least 1 year before
  • <10.5 g/dL of Hb without iron deficiency (serum ferritin level ≥50 ng/ml) or on erythropoiesis stimulating agents treatment regardless of iron status
  • With written informed consent

Exclusion Criteria:

  • On anticancer treatment
  • History of ischemic stroke or transient ischemic attack
  • Corrected serum calcium ≥10.5 mg/dL
  • HIV virus infection
  • Anticipated refractory hypertension by using epoetin beta pegol
  • In pregnancy and lactation
  • Current use of native vitamin D supplement
  • Patients ineligible according to the investigator's judgement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817699


Locations
Layout table for location information
Japan
CANDLE Trial Study Group
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
CANDLE-KIT Trial Study Group
Chugai Pharmaceutical
Japanese Society for the Promotion of Science
The Japan Kidney Foundation
Roche Diagnostics
Investigators
Layout table for investigator information
Study Director: Takayuki Hamano, MD, PhD Department of Inter-Organ Communication Research in Kidney Disease, Osaka University Graduate School of Medicine

Publications:

Layout table for additonal information
Responsible Party: CANDLE-KIT Trial Study Group
ClinicalTrials.gov Identifier: NCT01817699     History of Changes
Other Study ID Numbers: CKDR-001
UMIN000009970 ( Registry Identifier: UMIN Clinical Trials Registry )
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

Keywords provided by CANDLE-KIT Trial Study Group:
Cholecalciferol
Methoxy polyethylene glycol-epoetin beta
Hematinics
Bone Diseases, Metabolic
Neoplasms
Cardiovascular Diseases
Graft Rejection

Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Renal Insufficiency
Vitamin D Deficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents