Idiopathic Nephrotic Syndrome (INS)ALB-FFPNCT07685093
Comparison of Efficacy and Safety of Albumin Versus Fresh Frozen Plasma in Managing Diuretic Resistant Edema in Children With Idiopathic Nephrotic Syndrome.
A study testing Human Albumin 20% and Fresh Frozen Plasma in people with Idiopathic Nephrotic Syndrome (INS), run by Qamar Shafiq.
Trial summary
Edema is a major component of nephrotic syndrome (NS), defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines is, urine protein/creatinine ratio ≥ 2 mg/mg, and hypoalbuminemia ≤ 2.5 g/dl). Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Idiopathic Nephrotic Syndrome (INS)
- What is being tested?
- Human Albumin 20% and Fresh Frozen Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with an idiopathic nephrotic syndrome and diuretic resistant as per the definition • Children of either gender. • Children of 2-12 years of age
Who cannot join
- • Patients with secondary nephrotic syndrome/heart failure/hepatic dysfunction/severe renal impairment • Children with severe sepsis/hemodynamically unstable. • Children who had recent exchange transfusion • Parents refused to follow up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Efficacy and Safety of Albumin Versus Fresh Frozen Plasma in Managing Diuretic Resistant Edema in Children With Idiopathic Nephrotic Syndrome
Edema is a major component of nephrotic syndrome (NS), defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines is, urine protein/creatinine ratio ≥ 2 mg/mg, and hypoalbuminemia ≤ 2.5 g/dl). The causes of diuretic resistance include poor adherence to drug therapy or diet, pharmacokinetic issues, and compensatory sodium reabsorption. Impaired tubular secretion of diuretics is a common cause of diuretic resistance. The cornerstone of managing diuretic resistance is breaking the pathophysiological cycle. Fresh Frozen Plasma (FFP) is a viable, cost-effective alternative to intravenous albumin for managing diuretic resistant edema in children with idiopathic nephrotic syndrome (INS) but it may require more infusions than albumin.
The main purpose of the study is to compare the albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome The duration of study is six months after approval of synopsis. The study will be conducted in indoor Department of pediatric nephrology department, The Children's Hospital \& the Institute of Child Health, Multan. A sample size of 56 patients will be included in the study. Informed consent will be taken from included patients. The Group-A study population will be with intravenous albumin, 1 gm/kg/day in single daily dose over 4 hours followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be with intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg. Primary outcomes will be response to treatment in form of resolution of clinical signs within 72 hours of treatment. Secondary outcomes will be duration of hospital stay, mortality, complication of treatment, complications of disease and hearing assessment.
Data will be analyzed through SPSS v23. For quantitative variables, the mean standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. This study will provide a better opportunity to study Albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome in The Children's Hospital \& the Institute of Child Health, Multan
Read the detailed description
Edema is a major component of nephrotic syndrome (NS), defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines is, urine protein/creatinine ratio ≥ 2 mg/mg, and hypoalbuminemia ≤ 2.5 g/dl). Nephrotic syndrome is one of the most common pediatric renal diseases with an annual incidence of 1.2-16.9/100,000 children. It is characterized by edema, massive proteinuria (>40 mg/m2/h), and hypoalbuminemia (serum albumin <3 g/dL)(Kallash \& Mahan, 2021). Edema affects the quality of life of pediatric patients with NS, even when it is only mild to moderate in severity, and this is especially seen in patients with steroid resistant NS. Albumin infusions can be a highly effective method to treat edema in patients with NS. Edema can develop in nephrotic syndrome, chronic kidney disease (CKD), heart failure, and liver cirrhosis. Usually, the patients with edema respond to dietary sodium restriction in combination with a loop diuretic. However, some patients become resistant to diuretics. Diuretic resistance is defined as the failure to achieve the therapeutically desired reduction in edema even when a maximal dose of diuretic is employed (Hoorn \& Ellison, 2017).
The causes of diuretic resistance include poor adherence to drug therapy or diet, pharmacokinetic issues, and compensatory sodium reabsorption. Impaired tubular secretion of diuretics is a common cause of diuretic resistance. The cornerstone of managing diuretic resistance is breaking the pathophysiological cycle (Bell \& Mandalia, 2022). First-line management of edema involves sodium restriction and oral diuretics, most commonly loop diuretics like furosemide. However, a state of diuretic resistance often develops. This resistance is primarily due to two reasons reduced delivery: The hypoalbuminemia reduces the transport of furosemide to its site of action in the nephron, as the drug is highly protein-bound. Compensatory mechanisms are the intense activation of renin-angiotensin-aldosterone system and other neurohormonal pathways counteracts the natriuretic effect of diuretics, leading to rebound sodium retention (El-Halaby et al., 2022). Fresh Frozen Plasma (FFP) is a viable, cost-effective alternative to intravenous albumin for managing diuretic resistant edema in children with idiopathic nephrotic syndrome (INS) but it may require more infusions than albumin. FFP cost half than albumin and same duration required to reduce edema but with double number of infusion and it is safe in pediatric patients with NS presenting with moderate to severe edema. The cost-effectiveness may place FFP as a better choice especially in developing countries of the world (Al Mamun et al., 2015).
Due to availability of limited local data, the aim of this randomized control trial study is to evaluate the efficacy of albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome in children's hospital and institute of child health Multan Punjab Pakistan, so that the overall morbidity and mortality due to NS can be reduced
- Conditions
- Idiopathic Nephrotic Syndrome (INS)
- Being tested
- Human Albumin 20%, Fresh Frozen Plasma
- Keywords
- idiopathic nephrotic syndrome
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Albumin 20%Biological
The Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg
Fresh Frozen PlasmaBiological
The Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| albumin | Experimental | The Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg Receives: Biological: Human Albumin 20%; Biological: Fresh Frozen Plasma |
| fresh frozen plasma | Active comparator | The Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg Receives: Biological: Human Albumin 20%; Biological: Fresh Frozen Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to resolution of edema
primary outcome is time required to achieve clinically significant resolution of edema
Measured: baselines to 72 hours post intervention
Primary outcomes will be response to treatment in form of resolution of clinical signs within 24 to 48 hours of treatment
Primary outcomes will be response to treatment in form of resolution of clinical signs within 24 to 48 hours of treatment
Measured: 24 to 48 hours
Secondary outcomes (1)
change in serum albumin level
difference in serum albumin concentration measured before and after intervention in both study groups
Measured: baselines to 72 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start5 Jul 2026 (estimated)
- Primary completion17 Oct 2026 (estimated)
- Study completion17 Oct 2026 (estimated)
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 Idiopathic Nephrotic Syndrome (INS)Studies 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
- Model description
- albumin vs fresh frozen plasma in diuretic resistent edema in idiopathic nephrotic syndrome
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qamar Shafiq
- Sponsor type
- Other government
- Collaborators
- Children's Hospital and Institute of Child Health, Multan
- Responsible party
- Sponsor-investigator, Qamar Shafiq, Children's Hospital and Institute of Child Health, Multan
- Investigators
- Tariq aziz, MBBS FCPS, Principal investigator, Children's Hospital and Institute of Child Health, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685093
- Sponsor's protocol ID
- CHCMultan
- Acronym
- ALB-FFP
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will not be shared publically only summarized results will be published
Publications
Kallash, M., & Maha
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Albumin Versus Fresh Frozen Plasma in Managing Diuretic Resistant Edema in Children With Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT07685093
- Acronym / sponsor ID
- ALB-FFP / CHCMultan
- Conditions
- Idiopathic Nephrotic Syndrome (INS)
- Keywords
- idiopathic nephrotic syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Qamar ShafiqOther government
- Collaborators
- Children's Hospital and Institute of Child Health, Multan
- Study start
- 5 Jul 2026 (estimated)
- Primary completion
- 17 Oct 2026 (estimated)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- 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.
Edema is a major component of nephrotic syndrome (NS), defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines is, urine protein/creatinine ratio ≥ 2 mg/mg, and hypoalbuminemia ≤ 2.5 g/dl). The causes of diuretic resistance include poor adherence to drug therapy or diet, pharmacokinetic issues, and compensatory sodium reabsorption. Impaired tubular secretion of diuretics is a common cause of diuretic resistance. The cornerstone of managing diuretic resistance is breaking the pathophysiological cycle. Fresh Frozen Plasma (FFP) is a viable, cost-effective alternative to intravenous albumin for managing diuretic resistant edema in children with idiopathic nephrotic syndrome (INS) but it may require more infusions than albumin.
The main purpose of the study is to compare the albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome The duration of study is six months after approval of synopsis. The study will be conducted in indoor Department of pediatric nephrology department, The Children's Hospital \& the Institute of Child Health, Multan. A sample size of 56 patients will be included in the study. Informed consent will be taken from included patients. The Group-A study population will be with intravenous albumin, 1 gm/kg/day in single daily dose over 4 hours followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be with intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg. Primary outcomes will be response to treatment in form of resolution of clinical signs within 72 hours of treatment. Secondary outcomes will be duration of hospital stay, mortality, complication of treatment, complications of disease and hearing assessment.
Data will be analyzed through SPSS v23. For quantitative variables, the mean standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. This study will provide a better opportunity to study Albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome in The Children's Hospital \& the Institute of Child Health, Multan
Detailed description
Edema is a major component of nephrotic syndrome (NS), defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines is, urine protein/creatinine ratio ≥ 2 mg/mg, and hypoalbuminemia ≤ 2.5 g/dl). Nephrotic syndrome is one of the most common pediatric renal diseases with an annual incidence of 1.2-16.9/100,000 children. It is characterized by edema, massive proteinuria (>40 mg/m2/h), and hypoalbuminemia (serum albumin <3 g/dL)(Kallash \& Mahan, 2021). Edema affects the quality of life of pediatric patients with NS, even when it is only mild to moderate in severity, and this is especially seen in patients with steroid resistant NS. Albumin infusions can be a highly effective method to treat edema in patients with NS. Edema can develop in nephrotic syndrome, chronic kidney disease (CKD), heart failure, and liver cirrhosis. Usually, the patients with edema respond to dietary sodium restriction in combination with a loop diuretic. However, some patients become resistant to diuretics. Diuretic resistance is defined as the failure to achieve the therapeutically desired reduction in edema even when a maximal dose of diuretic is employed (Hoorn \& Ellison, 2017).
The causes of diuretic resistance include poor adherence to drug therapy or diet, pharmacokinetic issues, and compensatory sodium reabsorption. Impaired tubular secretion of diuretics is a common cause of diuretic resistance. The cornerstone of managing diuretic resistance is breaking the pathophysiological cycle (Bell \& Mandalia, 2022). First-line management of edema involves sodium restriction and oral diuretics, most commonly loop diuretics like furosemide. However, a state of diuretic resistance often develops. This resistance is primarily due to two reasons reduced delivery: The hypoalbuminemia reduces the transport of furosemide to its site of action in the nephron, as the drug is highly protein-bound. Compensatory mechanisms are the intense activation of renin-angiotensin-aldosterone system and other neurohormonal pathways counteracts the natriuretic effect of diuretics, leading to rebound sodium retention (El-Halaby et al., 2022). Fresh Frozen Plasma (FFP) is a viable, cost-effective alternative to intravenous albumin for managing diuretic resistant edema in children with idiopathic nephrotic syndrome (INS) but it may require more infusions than albumin. FFP cost half than albumin and same duration required to reduce edema but with double number of infusion and it is safe in pediatric patients with NS presenting with moderate to severe edema. The cost-effectiveness may place FFP as a better choice especially in developing countries of the world (Al Mamun et al., 2015).
Due to availability of limited local data, the aim of this randomized control trial study is to evaluate the efficacy of albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome in children's hospital and institute of child health Multan Punjab Pakistan, so that the overall morbidity and mortality due to NS can be reduced
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- albumin vs fresh frozen plasma in diuretic resistent edema in idiopathic nephrotic syndrome
| Arm | Type | Receives |
|---|---|---|
| albumin | Experimental | Biological: Human Albumin 20%, Biological: Fresh Frozen PlasmaThe Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg |
| fresh frozen plasma | Active comparator | Biological: Human Albumin 20%, Biological: Fresh Frozen PlasmaThe Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children diagnosed with an idiopathic nephrotic syndrome and diuretic resistant as per the definition • Children of either gender. • Children of 2-12 years of age
Key exclusion criteria (1 listed)
- • Patients with secondary nephrotic syndrome/heart failure/hepatic dysfunction/severe renal impairment • Children with severe sepsis/hemodynamically unstable. • Children who had recent exchange transfusion • Parents refused to follow up
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 |
|---|---|---|
| Human Albumin 20%The Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg | Biological | albumin, fresh frozen plasma |
| Fresh Frozen PlasmaThe Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg | Biological | albumin, fresh frozen plasma |
Primary outcome
time to resolution of edema
Time frame: baselines to 72 hours post intervention
primary outcome is time required to achieve clinically significant resolution of edema
Primary outcomes will be response to treatment in form of resolution of clinical signs within 24 to 48 hours of treatment
Time frame: 24 to 48 hours
Primary outcomes will be response to treatment in form of resolution of clinical signs within 24 to 48 hours of treatment
1 secondary outcome
change in serum albumin level
Time frame: baselines to 72 hours post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- BackgroundKallash, M., & Maha
- the description of refrences briefly explain the purpose and relevance of the cited literature in supporting the study background and rationale.Link provided by the sponsor.
- Individual participant dataSharing planned: No. data will not be shared publically only summarized results will be published
Related trials for Idiopathic Nephrotic Syndrome (INS)
RecruitingObservational study
INS, B Cells and Microbiota
Microbiota, B-lymphocytes
RecruitingObservational study
Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes
Idiopathic Nephrotic Syndrome (INS)
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.
Tariq aziz, MBBS FCPS principal investigator
Children's Hospital and Institute of Child Health, Multan
Questions about this trial
What is this clinical trial studying?
A study testing Human Albumin 20% and Fresh Frozen Plasma in people with Idiopathic Nephrotic Syndrome (INS), run by Qamar Shafiq.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qamar Shafiq, MBBS (00923076960500, qamarshafiq710@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to resolution of edema (time frame: baselines to 72 hours post intervention). The study lists 2 primary outcomes in all. 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 NCT07685093, 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 Jul 2026.