End Stage Renal DiseasePhase 2NCT02224144
Bone Mass and Strength After Kidney Transplantation
A Phase 2 study testing Vitamin D3 and Calcitriol in people with End Stage Renal Disease and Kidney Transplantation, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Kidney Transplantation, Bone Loss
- What is being tested?
- Vitamin D3 and Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2014to 12 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18
- Self-describes as White race
Who cannot join
- Lower extremity amputations
- Non-ambulatory
- Paget´s disease of bone
- Current hyperthyroidism, untreated hypothyroidism
- Medical diseases (end stage liver, intestinal malabsorption)
- Use within the prior year pod anti-seizure medications that induce the cytochrome P450 system, testosterone, estrogen, selective estrogen receptor modulators
Show all 10Show fewer
- Weight >300 pounds
- Dual organ transplant
- Myocardial infarction or stroke
- Tobacco use within the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.
Read the detailed description
Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.
- Conditions
- End Stage Renal Disease, Kidney Transplantation, Bone Loss, Fractures, Vascular Calcifications
- Being tested
- Vitamin D3, Calcitriol, Placebo
- Keywords
- Kidney Transplantation, Calcitriol, Bone Mineral Density, Bone Mass and Strength, Vascular Calcifications, Hyperparathyroidism, Parathyroid Hormone
- Medical subject headings
- Kidney Failure, Chronic, Bone Diseases, Metabolic, Fractures, Bone, Vascular Calcification, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called cholecalciferol
Vitamin D3 1000 IU per day for 12 months
CalcitriolDrug
Also called Rocaltrol
Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months
PlaceboDrug
Placebo (sugar pill) 1 pill per day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 plus Calcitriol | Experimental | 1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months
1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months Receives: Drug: Vitamin D3; Drug: Calcitriol |
| Vitamin D3 plus Placebo | Placebo comparator | 1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months
1 pill of placebo (sugar pill) per day for 12 months Receives: Drug: Vitamin D3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies
Novel high resolution bone imaging can separately measure and quantify cortical and trabecular responses to bone active treatments. Finite element analysis (FEA) can be applied to HRpQCT datasets. to provide a computational estimate of bone mechanical competence that has been validated against true compressive tests of bone stiffness and strength.
Measured: Baseline, 12 months
Secondary outcomes (7)
Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation
Apply imaging methods to shed light on whether preservation of areal bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) is accompanied by preservation of bone mechanical competence measured by a method that has been validated against true compressive tests of bone strength.
Measured: Baseline, 12 months
Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods
Failure load refers to the maximum amount of force a bone can withstand before it fractures. Volumetric BMD and microarchitecture of cortical and trabecular compartments were measured using HR-pQCT first- (XCT1) and second-generation scanners (XCT2), with voxel size 82 μm and 60 μm respectively. HR-pQCT imaging was performed on the non-dominant radius and tibia.
Measured: Baseline, 12 months
Percent Change of Cortical Porosity Pre- and Post-intervention
Cortical porosity was calculated as the percentage of void space in the cortex. HR-pQCT imaging was performed on the non-dominant radius and tibia.
Measured: Baseline, 12 months
Percent Change in Vascular Calcifications Loads of the Lower Extremity
A semi-automated algorithm implemented in image processing language was used for assessment of lower leg arterial calcification (LLAC) and wrist arterial calcification (WAC).
Measured: Baseline, 12 months
Number of Patients With Vascular Calcifications of the Lower Extremity
Quantification of calcifications of the anterior and posterior tibia arteries measured by a novel method applied to HRpQCT at baseline and 12 months.
Measured: Baseline, 12 months
Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels
PTH levels were measured in participants to confirm the hypothesis that calcitriol administration over the first year of kidney transplantation would protect the cortical skeleton in recipients managed without corticosteroids due to its ability to suppress PTH and bone remodeling.
Measured: Baseline, 12 months
Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment
Participants underwent a blood draw for measurement of bone markers: bone-specific alkaline phosphatase (BSAP), propeptide of type 1 procollagen (P1NP), osteocalcin (OC), and the bone resorption marker serum cross-linked C-telopeptide of type I collagen (CTX).
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study start18 Aug 2014
- Primary completion12 Oct 2016
- Study completion12 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Satellite Healthcare
- Responsible party
- Sponsor
- Investigators
- Thomas Nickolas, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224144
- Sponsor's protocol ID
- AAAM7850
- Status last verified
- Mar 2025
- First submitted
- 22 Aug 2014
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iyer SP, Nikkel LE, Nishiyama KK, Dworakowski E, Cremers S, Zhang C, McMahon DJ, Boutroy S, Liu XS, Ratner LE, Cohen DJ, Guo XE, Shane E, Nickolas TL. Kidney transplantation with early corticosteroid withdrawal: paradoxical effects at the central and peripheral skeleton. J Am Soc Nephrol. 2014 Jun;25(6):1331-41. doi: 10.1681/ASN.2013080851. Epub 2014 Feb 7.
PubMed 24511131
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02224144
- Acronym / sponsor ID
- AAAM7850
- Conditions
- End Stage Renal Disease, Kidney Transplantation, Bone Loss, Fractures, Vascular Calcifications
- Keywords
- Kidney Transplantation, Calcitriol, Bone Mineral Density, Bone Mass and Strength, Vascular Calcifications, Hyperparathyroidism, Parathyroid Hormone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Satellite Healthcare
- Study start
- 18 Aug 2014 (actual)
- Primary completion
- 12 Oct 2016 (actual)
- Study completion
- 12 Oct 2016 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.
Detailed description
Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 plus Calcitriol | Experimental | Drug: Vitamin D3, Drug: Calcitriol1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months 1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months |
| Vitamin D3 plus Placebo | Placebo comparator | Drug: Vitamin D3, Drug: Placebo1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months 1 pill of placebo (sugar pill) per day for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age older than 18
- Self-describes as White race
Key exclusion criteria (10 listed)
- Lower extremity amputations
- Non-ambulatory
- Paget´s disease of bone
- Current hyperthyroidism, untreated hypothyroidism
- Medical diseases (end stage liver, intestinal malabsorption)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferolVitamin D3 1000 IU per day for 12 months | Drug | Vitamin D3 plus Calcitriol, Vitamin D3 plus Placebo |
| CalcitriolAlso: RocaltrolCalcitriol (Rocaltrol) 0.5 mcg per day for 12 months | Drug | Vitamin D3 plus Calcitriol |
| PlaceboPlacebo (sugar pill) 1 pill per day for 12 months | Drug | Vitamin D3 plus Placebo |
Primary outcome
Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies
Time frame: Baseline, 12 months
Novel high resolution bone imaging can separately measure and quantify cortical and trabecular responses to bone active treatments. Finite element analysis (FEA) can be applied to HRpQCT datasets. to provide a computational estimate of bone mechanical competence that has been validated against true compressive tests of bone stiffness and strength.
7 secondary outcomes
Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation
Time frame: Baseline, 12 months
Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods
Time frame: Baseline, 12 months
Percent Change of Cortical Porosity Pre- and Post-intervention
Time frame: Baseline, 12 months
Percent Change in Vascular Calcifications Loads of the Lower Extremity
Time frame: Baseline, 12 months
Number of Patients With Vascular Calcifications of the Lower Extremity
Time frame: Baseline, 12 months
Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels
Time frame: Baseline, 12 months
Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment
Time frame: Baseline, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24511131Iyer SP, Nikkel LE, Nishiyama KK, Dworakowski E, Cremers S, Zhang C, McMahon DJ, Boutroy S, Liu XS, Ratner LE, Cohen DJ, Guo XE, Shane E, Nickolas TL. Kidney transplantation with early corticosteroid withdrawal: paradoxical effects at the central and peripheral skeleton. J Am Soc Nephrol. 2014 Jun;25(6):1331-41. doi: 10.1681/ASN.2013080851. Epub 2014 Feb 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Nickolas, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 and Calcitriol in people with End Stage Renal Disease and Kidney Transplantation, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.