HyperparathyroidismNCT00800358
Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism
A study testing Paricalitol and Calcitriol in people with Hyperparathyroidism and Kidney Disease, run by Penang Hospital, Malaysia at 11 sites in Malaysia.
Trial summary
The purpose of this study is to determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic kidney disease patients undergoing dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Kidney Disease
- What is being tested?
- Paricalitol and Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 11 sitesMalaysia
- Study dates
- Nov 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 at or above 18 years
- End stage renal disease on regular maintenance haemodialysis or peritoneal dialysis for at least 3 months
- iPTH level of 300 pg/ml or greater at baseline
- Written informed consent by subject or guardian
- Female patients will either be post-menopausal for more than 2 years, surgically sterile or if of childbearing age, using double contraception
Who cannot join
- Baseline calcium value more than 2.87 mmol/L
- Baseline Ca x P of greater than 5.63 mmol2/l2
- Positive for HBsAg or Hepatitis C with raised ALT twice above upper limit of normal or evidence of liver cirrhosis
- Clinically significant gastrointestinal disease
- History of allergic reaction to calcitriol or other vitamin D compounds
- Inability or unwillingness to provide written consent.
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- Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- Pregnancy, breastfeeding or use of non-reliable method of contraception.
- Use of medications prohibited prior to randomization such as ketoconazole and other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir
- Necessity for calcitonin, biphosphonates, maintenance oral or intravenous glucocorticoid or cinacalcet or other drugs that may affect calcium or bone metabolism.
- Alcohol or substance abuse within 6 months prior to screening
- Other medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
- Participation in another clinical trial and/or receipt of investigational drugs within 4 weeks prior to screening visit.
- If PD subjects had active peritonitis within one month prior to the screening visit
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Malaysia11 sites
Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar
Alor Star, Kedah, 05460
Clinical Research Centre, Penang Hospital
George Town, Pulau Pinang, 10990
Nephrology Department, Tengku Ampuan Rahimah Hospital
Klang, Selangor, 41200
Hemodialysis Unit, Raja Perempuan Zainab II Hospital
Kota Bharu, Kelantan, 15586
Hemodialysis Unit, Kuala Lumpur Hospital
Kuala Lumpur, Selangor, 50586
Hemodialysis Unit, Tengku Ampuan Afzan Hospital
Kuantan, Pahang, 25100
Haemodialysis Unit, Melaka Hospital
Malacca, Melaka, 75400
Haemodialysis Unit, Seberang Jaya Hospital
Seberang Jaya, Pulau Pinang, 13700
Haemodialysis Unit, Serdang Hospital
Serdang, Selangor, 43000
Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital
Seremban, Selangor, 70300
Hemodialysis Unit, Taiping Hospital
Taiping, Perak, 34000
About this study
Official title: A Multi Centre, Open Label, Parallel Group, Randomized Controlled Trial to Compare the Safety and Efficacy of Oral Paricalcitol Versus Oral Calcitriol in the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
The purpose of this study is to determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic kidney disease patients undergoing dialysis.
Read the detailed description
Secondary hyperparathyroidism, a common consequence of chronic kidney disease, results from abnormal regulation of calcium and phosphate homeostasis. The early administration of calcium supplements or vitamin D attenuates the development and progression of hyperparathyroidism, preventing or retarding the emergence of many of the serious complications of chronic kidney disease. However, these vitamin D derivatives also have serious side effects, including hypercalcemia and hyperphosphatemia and, as a result, a high level of the calcium-phosphate product. These adverse outcomes have prompted the development of novel, "nonhypercalcemic" vitamin D analogues. Three of these analogues have recently been marketed for clinical use in patients with chronic kidney disease: 19-nor-1,25-dihydroxyvitamin D2 (paricalcitol), 1 -hydroxyvitamin D2 (doxercalciferol), and 22-oxacalcitriol.
Oral paricalcitol was developed to provide a convenient, alternative therapy, particularly for Peritoneal Dialysis patients in whom regular intravenous administration of paricalcitol is not practical. This study is designed to determine the proportion of patients with 'End stage renal failure' on haemodialysis or peritoneal dialysis and secondary hyperparathyroidism who achieved more than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.
- Conditions
- Hyperparathyroidism, Kidney Disease
- Being tested
- Paricalitol, Calcitriol
- Keywords
- Secondary hyperparathyroidism, End stage renal disease, Haemodialysis, Peritoneal dialysis, Paricalcitol (Zemplar), Calcitriol
- Medical subject headings
- Hyperparathyroidism, Kidney Diseases, Hyperparathyroidism, Secondary, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalitolDrug
Also called Zemplar
oral paricalcitol variable daily dosing based on intact PTH level for 6 months
CalcitriolDrug
oral calcitriol variable daily dosing based on intact PTH level for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral Paricalcitol in varying doses Receives: Drug: Paricalitol |
| 2 | Active comparator | Calcitriol Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.
Measured: 24 weeks
Secondary outcomes (2)
Quantum of reduction in alkaline phosphatase level, Time duration to achieve the target level of iPTH. (Titration time), Serum Calcium, phosphate, Ca x Po4 product change from baseline
Measured: 24 weeks
Incidence of hypercalcaemic episodes
Measured: Through out 24 weeks of participation from the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Dr.Ong Loke Meng, Penang Hospital, Malaysia
- Investigators
- Ong L Meng, MBBS, MRCP, Principal investigator, Clinical Research Centre, Penang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800358
- Sponsor's protocol ID
- Protocol No: CT 08-02
- Status last verified
- Dec 2012
- First submitted
- 30 Nov 2008
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ong LM, Narayanan P, Goh HK, Manocha AB, Ghazali A, Omar M, Mohamad S, Goh BL, Shah S, Seman MR, Vaithilingam I, Ghazalli R, Rahmat K, Shaariah W, Ching CH; Oral Paricalcitol in ESRD Study Group. Randomized controlled trial to compare the efficacy and safety of oral paricalcitol with oral calcitriol in dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2013 Mar;18(3):194-200. doi: 10.1111/nep.12029.
PubMed 23311404
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Centre, Open Label, Parallel Group, Randomized Controlled Trial to Compare the Safety and Efficacy of Oral Paricalcitol Versus Oral Calcitriol in the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00800358
- Acronym / sponsor ID
- Protocol No: CT 08-02
- Conditions
- Hyperparathyroidism, Kidney Disease
- Keywords
- Secondary hyperparathyroidism, End stage renal disease, Haemodialysis, Peritoneal dialysis, Paricalcitol (Zemplar), Calcitriol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Collaborators
- Ministry of Health, Malaysia
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
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 determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic kidney disease patients undergoing dialysis.
Detailed description
Secondary hyperparathyroidism, a common consequence of chronic kidney disease, results from abnormal regulation of calcium and phosphate homeostasis. The early administration of calcium supplements or vitamin D attenuates the development and progression of hyperparathyroidism, preventing or retarding the emergence of many of the serious complications of chronic kidney disease. However, these vitamin D derivatives also have serious side effects, including hypercalcemia and hyperphosphatemia and, as a result, a high level of the calcium-phosphate product. These adverse outcomes have prompted the development of novel, "nonhypercalcemic" vitamin D analogues. Three of these analogues have recently been marketed for clinical use in patients with chronic kidney disease: 19-nor-1,25-dihydroxyvitamin D2 (paricalcitol), 1 -hydroxyvitamin D2 (doxercalciferol), and 22-oxacalcitriol.
Oral paricalcitol was developed to provide a convenient, alternative therapy, particularly for Peritoneal Dialysis patients in whom regular intravenous administration of paricalcitol is not practical. This study is designed to determine the proportion of patients with 'End stage renal failure' on haemodialysis or peritoneal dialysis and secondary hyperparathyroidism who achieved more than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ParicalitolOral Paricalcitol in varying doses |
| 2 | Active comparator | Drug: CalcitriolCalcitriol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at or above 18 years
- End stage renal disease on regular maintenance haemodialysis or peritoneal dialysis for at least 3 months
- iPTH level of 300 pg/ml or greater at baseline
- Written informed consent by subject or guardian
- Female patients will either be post-menopausal for more than 2 years, surgically sterile or if of childbearing age, using double contraception
Key exclusion criteria (14 listed)
- Baseline calcium value more than 2.87 mmol/L
- Baseline Ca x P of greater than 5.63 mmol2/l2
- Positive for HBsAg or Hepatitis C with raised ALT twice above upper limit of normal or evidence of liver cirrhosis
- Clinically significant gastrointestinal disease
- History of allergic reaction to calcitriol or other vitamin D compounds
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 |
|---|---|---|
| ParicalitolAlso: Zemplaroral paricalcitol variable daily dosing based on intact PTH level for 6 months | Drug | 1 |
| Calcitrioloral calcitriol variable daily dosing based on intact PTH level for 6 months | Drug | 2 |
Primary outcome
More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.
Time frame: 24 weeks
2 secondary outcomes
Quantum of reduction in alkaline phosphatase level, Time duration to achieve the target level of iPTH. (Titration time), Serum Calcium, phosphate, Ca x Po4 product change from baseline
Time frame: 24 weeks
Incidence of hypercalcaemic episodes
Time frame: Through out 24 weeks of participation from the time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Derived from this study: PubMed 23311404Ong LM, Narayanan P, Goh HK, Manocha AB, Ghazali A, Omar M, Mohamad S, Goh BL, Shah S, Seman MR, Vaithilingam I, Ghazalli R, Rahmat K, Shaariah W, Ching CH; Oral Paricalcitol in ESRD Study Group. Randomized controlled trial to compare the efficacy and safety of oral paricalcitol with oral calcitriol in dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2013 Mar;18(3):194-200. doi: 10.1111/nep.12029.
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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.
Ong L Meng, MBBS, MRCP principal investigator
Clinical Research Centre, Penang Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paricalitol and Calcitriol in people with Hyperparathyroidism and Kidney Disease, run by Penang Hospital, Malaysia at 11 sites in Malaysia.
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 5 inclusion and 14 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 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Malaysia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules. (time frame: 24 weeks). 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 NCT00800358, 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 6 Dec 2012.