Type 2 DiabetesPhase 2PROCEEDNCT01393808
Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes
A Phase 2 study testing Paricalcitol in people with Type 2 Diabetes, run by Mario Negri Institute for Pharmacological Research at 6 sites in Italy.
Trial summary
Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for renal disease progression. More proteinuria is associated with faster progression, whereas treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Paricalcitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 6 sitesItaly
- Study dates
- Sep 2011to Jul 2015
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients;
- Age > 18 years;
- Type 2 diabetes patients on low or high sodium diet and stable RAS inhibitor therapy with the following conditions:
- Urinary albumin excretion (UAE) rate >300mg/24 hours (200 mcg/min); Serum creatinine <2 mg/dL, PTH ≥ 20 mEq/L and <110 mEq/L; Calcium and phosphorus levels < 9.5 mg/dl and < 5mg/dl, respectively; Controlled BP (systolic/diastolic <140/90 mmHg) while on stable RAS inhibitor therapy;
- Written informed consent.
Who cannot join
- Previous Vitamin D or Vitamin D analogs therapy (within 3 months prior to the study entry);
- Evidence of toxicity to Vitamin D;
- History of kidney stones;
- Poorly controlled Diabetes: Hb1Ac > 12%;
- Therapy with calcitonin, bisphosphonates, cinacalcet, glucocorticoids, immunosuppressive drugs or other drug that may affect calcium or bone metabolism;
- Cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study;
Show all 11Show fewer
- Any clinically relevant conditions that might affect study participation and/or study results;
- Any contraindication to be exposed to Paricalcitol;
- Pregnancy or lactating;
- Women of childbearing potential without following a scientifically accepted form of contraception;
- Legal incapacity.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo, Bergamo
ASL of Ponte San Pietro - Diabetologic Unit
Brembate, Bergamo, 24030
Clinical Research Center fo Rare Diseases Aldo and Cele Daccò
Ranica, Bergamo, 24020
Azienda Ospedaliera di Treviglio e Caravaggio - Unit of Diabetology and Metabolic Diseases
Romano di Lombardia, BG
Azienda Ospedaliera Bolognini - Unità di Medicina
Seriate, BG
Azienda Ospedaliera di Treviglio e Caravaggio - Unit of Diabetology and Metabolic Diseases
Treviglio, BG
About this study
Official title: A Prospective, Randomized, Cross-over, Double-blind, Placebo-controlled Study to Assess the Antiproteinuric Effect of Selective Vitamin d Receptor Activation by Paricalcitol in Type 2 Diabetes Patients on Low or High Sodium Diet and Stable Ras Inhibitor Therapy
Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for renal disease progression. More proteinuria is associated with faster progression, whereas treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower is the disease progression in the long term. On the basis of the above findings, proteinuria has become a target of renoprotective therapy.
Among different antihypertensive medications, those that inhibit the Renin Angiotensin System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce proteinuria and slow renal disease progression. Thus they have become the key component of renoprotective therapy in patients with proteinuric chronic kidney disease. Observational studies found that their effectiveness, however, is limited or even fully blunted in patients who eat large amount of salt.
Read more
Experimental evidence indicates a renoprotective role of the vitamin D system in chronic renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor therapy. This effect, however, was largely restricted to subjects with daily sodium intake exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with paricalcitol appears to be effective in particular in those patients who do not appreciably benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake. Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is worth investigating.
The broad aim of this study is to evaluate the interaction between paricalcitol therapy and sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable background RAS inhibitor therapy.
- Conditions
- Type 2 Diabetes
- Being tested
- Paricalcitol, placebo
- Keywords
- Type 2 diabetes, Paricalcitol, Proteinuria, Sodium intake
- Medical subject headings
- Diabetes Mellitus, Type 2, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
1-month Paricalcitol 2mcg/day
placeboOther
1-month Placebo Treatment
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Experimental | Not described Receives: Drug: Paricalcitol |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urinary albumin excretion from baseline at 4 month.
Measured: At baseline and 1,2,3 and 4 month.
Secondary outcomes (4)
Ambulatory and 24-hour blood pressure profile.
Measured: At 1 month.
Ambulatory and 24-hour blood pressure profile.
Measured: At 2 month.
Ambulatory and 24-hour blood pressure profile.
Measured: At 3 month.
Ambulatory and 24-hour blood pressure profile.
Measured: At 4 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393808
- Sponsor's protocol ID
- PROCEED
- Other IDs
- 2011-001713-14
- Acronym
- PROCEED
- Status last verified
- Mar 2017
- First submitted
- 12 Jul 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodson EM, Cooper TE. Altered dietary salt intake for preventing diabetic kidney disease and its progression. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD006763. doi: 10.1002/14651858.CD006763.pub3.
PubMed 36645291Prabhu RA, Saraf K. Vitamin D in diabetic nephropathy. J Postgrad Med. 2018 Jan-Mar;64(1):5-6. doi: 10.4103/jpgm.JPGM_311_17. No abstract available.
PubMed 29386411Parvanova A, Trillini M, Podesta MA, Iliev IP, Ruggiero B, Abbate M, Perna A, Peraro F, Diadei O, Rubis N, Gaspari F, Carrara F, Stucchi N, Belviso A, Bossi AC, Trevisan R, Remuzzi G, de Borst M, Ruggenenti P; PROCEED Study Organization and the Scientific Writing Academy (SWA) 2016. Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):27-40. doi: 10.1016/S2213-8587(17)30359-5. Epub 2017 Nov 2.
PubMed 29104158
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Cross-over, Double-blind, Placebo-controlled Study to Assess the Antiproteinuric Effect of Selective Vitamin d Receptor Activation by Paricalcitol in Type 2 Diabetes Patients on Low or High Sodium Diet and Stable Ras Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT01393808
- Acronym / sponsor ID
- PROCEED / PROCEED
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Paricalcitol, Proteinuria, Sodium intake
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jul 2011 (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.
Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for renal disease progression. More proteinuria is associated with faster progression, whereas treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower is the disease progression in the long term. On the basis of the above findings, proteinuria has become a target of renoprotective therapy.
Among different antihypertensive medications, those that inhibit the Renin Angiotensin System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce proteinuria and slow renal disease progression. Thus they have become the key component of renoprotective therapy in patients with proteinuric chronic kidney disease. Observational studies found that their effectiveness, however, is limited or even fully blunted in patients who eat large amount of salt.
Experimental evidence indicates a renoprotective role of the vitamin D system in chronic renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor therapy. This effect, however, was largely restricted to subjects with daily sodium intake exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with paricalcitol appears to be effective in particular in those patients who do not appreciably benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake. Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is worth investigating.
The broad aim of this study is to evaluate the interaction between paricalcitol therapy and sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable background RAS inhibitor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Experimental | Drug: Paricalcitol |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients;
- Age > 18 years;
- Type 2 diabetes patients on low or high sodium diet and stable RAS inhibitor therapy with the following conditions:
- Urinary albumin excretion (UAE) rate >300mg/24 hours (200 mcg/min); Serum creatinine <2 mg/dL, PTH ≥ 20 mEq/L and <110 mEq/L; Calcium and phosphorus levels < 9.5 mg/dl and < 5mg/dl, respectively; Controlled BP (systolic/diastolic <140/90 mmHg) while on stable RAS inhibitor therapy;
- Written informed consent.
Key exclusion criteria (11 listed)
- Previous Vitamin D or Vitamin D analogs therapy (within 3 months prior to the study entry);
- Evidence of toxicity to Vitamin D;
- History of kidney stones;
- Poorly controlled Diabetes: Hb1Ac > 12%;
- Therapy with calcitonin, bisphosphonates, cinacalcet, glucocorticoids, immunosuppressive drugs or other drug that may affect calcium or bone metabolism;
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 |
|---|---|---|
| Paricalcitol1-month Paricalcitol 2mcg/day | Drug | Paricalcitol |
| placebo1-month Placebo Treatment | Other | placebo |
Primary outcome
Changes in urinary albumin excretion from baseline at 4 month.
Time frame: At baseline and 1,2,3 and 4 month.
4 secondary outcomes
Ambulatory and 24-hour blood pressure profile.
Time frame: At 1 month.
Ambulatory and 24-hour blood pressure profile.
Time frame: At 2 month.
Ambulatory and 24-hour blood pressure profile.
Time frame: At 3 month.
Ambulatory and 24-hour blood pressure profile.
Time frame: At 4 month.
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 3 Mar 2017.
- Derived from this study: PubMed 36645291Hodson EM, Cooper TE. Altered dietary salt intake for preventing diabetic kidney disease and its progression. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD006763. doi: 10.1002/14651858.CD006763.pub3.
- Derived from this study: PubMed 29386411Prabhu RA, Saraf K. Vitamin D in diabetic nephropathy. J Postgrad Med. 2018 Jan-Mar;64(1):5-6. doi: 10.4103/jpgm.JPGM_311_17. No abstract available.
- Derived from this study: PubMed 29104158Parvanova A, Trillini M, Podesta MA, Iliev IP, Ruggiero B, Abbate M, Perna A, Peraro F, Diadei O, Rubis N, Gaspari F, Carrara F, Stucchi N, Belviso A, Bossi AC, Trevisan R, Remuzzi G, de Borst M, Ruggenenti P; PROCEED Study Organization and the Scientific Writing Academy (SWA) 2016. Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):27-40. doi: 10.1016/S2213-8587(17)30359-5. Epub 2017 Nov 2.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paricalcitol in people with Type 2 Diabetes, run by Mario Negri Institute for Pharmacological Research at 6 sites in Italy.
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 11 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
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?
Changes in urinary albumin excretion from baseline at 4 month. (time frame: At baseline and 1,2,3 and 4 month.). 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 NCT01393808, which also lists 3 linked publications.
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 3 Mar 2017.