Clinical trial to evaluate the effect of vitamin D on renal progression in patients with Chronic Kidney Disease and vitamin D deficiency

Phase II clinical trial to evaluate the effect of 25 OH vitamin D on renal progression in patients with Chronic Kidney Disease stage 3 and 25OH vitamin D deficiency - VITARENAL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002913-23-ES

Enrollment

170

Registered

2016-08-29

Start date

2016-10-05

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease in patients with D vitamin deficit

Interventions

Trade Name: DELTIUS 25000 Product Code: A11CC05 Pharmaceutical Form: Oral solution in single-dose container

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age 18-80 years • Stage 3 Kidney Disease ( CKD EPI eGFR 60-30 ml / min / 1.73m2 ) • 25 OH vitamin D levels 30 mg / g confirmed in first morning urine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: • Bone fracture in the last three months • Previous condition of intestinal malabsorption or chronic diarrhea. • Treatment with phenobarbital, phenytoin , rifampin , sucralfate , digoxin , steroids or other medication may affect the metabolism of vitamin D • Previous liver failure • Primary hyperparathyroidism • calcimimetic treatment in the last 6 months • active granulomatous disease • Current treatment with some form of vitamin D • Pregnancy- lactation • Background of calcium nephrolithiasis well documented origin • serum phosphate > 5.5 mg / dL in any determination in the last 3 months • Serum calcium > 10.0 mg / dL in any determination in the last 3 months

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the progression of CKD defined as the number of patients increasing by 50 % the baseline serum creatinine value or reach CKD stage 5 , dialysis or transplantation , or death between the group receiving 25 OH vitamin D and the group without active treatment; Secondary Objective: - Compare proteinuria decrease between groups - To evaluate and compare the safety and tolerance to treatment with 25 OH vitamin D - Compare cardiovascular morbidity and mortality (death from CV causes , MI, hospitalization for heart failure , coronary angiography and / or coronary revascularization , stroke, and amputation and / or revascularization of lower limbs ) between groups - Compare the time of diagnosis of secondary hyperparathyroidism (PTH KDOQI > 250 pg / mL ) between groups ; Primary end point(s): - Number of patients with increased serum creatinine value of at least 50% compared to baseline , reach stage 5 CKD ( CKD-EPI eGFR 11 mg/dl ;Timepoint(s) of evaluation of this end point: Every study visit (10 visits every 2-4 months)	—

Measure

Time frame

Main Objective: Compare the progression of CKD defined as the number of patients increasing by 50 % the baseline serum creatinine value or reach CKD stage 5 , dialysis or transplantation , or death between the group receiving 25 OH vitamin D and the group without active treatment; Secondary Objective: - Compare proteinuria decrease between groups - To evaluate and compare the safety and tolerance to treatment with 25 OH vitamin D - Compare cardiovascular morbidity and mortality (death from CV causes , MI, hospitalization for heart failure , coronary angiography and / or coronary revascularization , stroke, and amputation and / or revascularization of lower limbs ) between groups - Compare the time of diagnosis of secondary hyperparathyroidism (PTH KDOQI > 250 pg / mL ) between groups ; Primary end point(s): - Number of patients with increased serum creatinine value of at least 50% compared to baseline , reach stage 5 CKD ( CKD-EPI eGFR 11 mg/dl ;Timepoint(s) of evaluation of this end point: Every study visit (10 visits every 2-4 months)

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Secondary

Measure	Time frame
Secondary end point(s): - Proportion of patients with proteinuria reduction > 50% from baseline - Proportion of patients achieving KDOQI PTH > 250 pg / mL ) - Average time that patients reach KDOQI PTH > 250 pg / mL ) - Number and severity of any Adverse Reaction - Withdrawals due to D3 vitamin secondary effects or D3 vitamin intolerance - Number of patients with hyperphosphoremia > 5.5 mg/dl ;Timepoint(s) of evaluation of this end point: Every study visit (10 visits every 2-4 months)	—

Measure

Time frame

Secondary end point(s): - Proportion of patients with proteinuria reduction > 50% from baseline - Proportion of patients achieving KDOQI PTH > 250 pg / mL ) - Average time that patients reach KDOQI PTH > 250 pg / mL ) - Number and severity of any Adverse Reaction - Withdrawals due to D3 vitamin secondary effects or D3 vitamin intolerance - Number of patients with hyperphosphoremia > 5.5 mg/dl ;Timepoint(s) of evaluation of this end point: Every study visit (10 visits every 2-4 months)

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Countries

Spain

Contacts

Public ContactMarta del Álamo

Spanich Clinical Research Network

martadelalamo.hrc@gmail.com+34913368825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026